Recall archive / FDA device enforcement
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 — FDA record Z-1302-2024
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 Feb 12, 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 POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
- Reason
- Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).
- Classification
- Class I
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 461 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1302-2024
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 | GTIN 08714729992684, Batch Numbers: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 3, 2024
- Recall initiation date
- Feb 12, 2024
- Center classification date
- Mar 26, 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.