Recall archive / FDA device enforcement
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 — FDA record Z-0238-2024
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 Sep 7, 2023. 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
- Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
- Reason
- Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
- Classification
- Class II
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 185
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0238-2024
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 | UDI-DI: 00690103043532, Lot: 64936927 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
OUS: Singapore, Taiwan, Canada
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 15, 2023
- Recall initiation date
- Sep 7, 2023
- Center classification date
- Nov 6, 2023
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.