Recall archive / FDA device enforcement
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the va... — FDA record Z-1041-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 3, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded. There are a total of 208 Optima Coil models. Optima Coil Model Numbers and Product description: OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft...
- Reason
- Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
- Classification
- Class II
- Recalling firm
- BALT USA, LLC
- Quantity
- 31785 coils
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1041-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Refer to Attachment 1 for list of affected products including the products' Lot Number, Product model number, UDI and expiration date. Optima Coils ( Lot Number/Model Number/Product Description/UDI-DI Code: F201000528 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F201200957 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210100206 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210200292 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210200541 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210300015 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053026614 F210301053 OPTI0151HSS10 Optima Coil 1.5mm x 1cm Helical-10 SuperSoft 00818053022128 F201000069 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201000337 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201000484 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201000927 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201001145 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100048 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F201100121 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100149 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100164 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100280 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100302 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100344 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100418 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201100469 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F201100501 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F201100613 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201200023 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201200033 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F201200162 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201200176 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F201200687 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201200748 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F201201117 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100085 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100237 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100246 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100285 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100453 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100913 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100922 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210100973 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F210200003 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210200071 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053021411 F210200099 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F210200105 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053022135 F210200109 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F210200176 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210200177 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210200259 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053022135 F210200268 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210200410 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210200524 OPTI0152CSS10 Optima Coil 1.5mm x 2cm Complex-10 SuperSoft 00818053025747 F210300392 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F210500140 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F210500293 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F210800632 OPTI0152HSS10 Optima Coil 1.5mm x 2cm Helical-10 SuperSoft 00818053026621 F200800331 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053021428 F200900369 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F200900373 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201000075 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201000438 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201000485 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201000928 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201001146 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201001157 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F201100030 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053021428 F201100083 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201100150 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201100234 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201100345 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201100371 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053022142 F201100410 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F201100426 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201100489 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053021428 F201100507 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201100527 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201100536 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201100606 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F201200375 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F201200933 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201200958 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F201201118 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201201146 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F201201179 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F210100036 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210100086 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210100112 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210100238 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210100247 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210100319 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210100423 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053022142 F210100773 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210100805 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210200048 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053021428 F210200049 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210200053 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F210200083 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210200115 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F210200258 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053022142 F210200394 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210200413 OPTI0153CSS10 Optima Coil 1.5mm x 3cm Complex-10 SuperSoft 00818053025754 F210300208 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F210300422 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F210800634 OPTI0153HSS10 Optima Coil 1.5mm x 3cm Helical-10 SuperSoft 00818053026638 F200900377 OPTI0154HSS10 Optima Coil 1.5mm x 4cm Helical-10 SuperSoft 00818053026645 F201000139 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201000150 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201000297 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100049 OPTI0154HSS10 Optima Coil 1.5mm x 4cm Helical-10 SuperSoft 00818053026645 F201100075 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053021435 F201100084 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100152 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100195 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100307 OPTI0154HSS10 Optima Coil 1.5mm x 4cm Helical-10 SuperSoft 00818053026645 F201100315 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100323 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100333 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100372 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100374 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100377 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100389 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100427 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100482 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201100494 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053021435 F201200024 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201200034 OPTI0154HSS10 Optima Coil 1.5mm x 4cm Helical-10 SuperSoft 00818053026645 F201200777 OPTI0154HSS10 Optima Coil 1.5mm x 4cm Helical-10 SuperSoft 00818053026645 F201200785 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201200787 OPTI0154HSS10 Optima Coil 1.5mm x 4cm Helical-10 SuperSoft 00818053026645 F201200800 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201200934 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201201119 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F201201181 OPTI0154HSS10 Optima Coil 1.5mm x 4cm Helical-10 SuperSoft 00818053026645 F210100002 OPTI0154HSS10 Optima Coil 1.5mm x 4cm Helical-10 SuperSoft 00818053026645 F210100037 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F210100087 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F210100114 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F210100239 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F210100248 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F210100286 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F210100320 OPTI0154CSS10 Optima Coil 1.5mm x 4cm Complex-10 SuperSoft 00818053025761 F210100974 OPTI0154HSS10 Optima Coil 1.5mm x 4cm Helical-10 ... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI and Puerto Rico O.U.S.: Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Ecuador, France, Indonesia, India, Japan, Korea, Malaysia, Mexico, Panama, Paraguay, Peru, Russia, Uruguay, and Vietnam.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 14, 2024
- Recall initiation date
- Jan 3, 2024
- Center classification date
- Feb 8, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.