Recall archive / FDA device enforcement
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100 — FDA record Z-0298-2025
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 Oct 10, 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
- Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
- Reason
- Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- Classification
- Class I
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 20290 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0298-2025
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 | GTIN 08714729992660 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 20, 2024
- Recall initiation date
- Oct 10, 2024
- Center classification date
- Nov 12, 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.