Recall archive / FDA device enforcement
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC — FDA record Z-1487-2023
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 Mar 24, 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
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
- Reason
- There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- Classification
- Class I
- Recalling firm
- Cordis US Corp
- Quantity
- 146 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1487-2023
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 20705032056943; Lot Numbers: 35265335, 35264202 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 17, 2023
- Recall initiation date
- Mar 24, 2023
- Center classification date
- May 11, 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.