Z-1302-2024 Class I Ongoing
FDA device recall Z-1302-2024 was initiated by Boston Scientific Corporation on Feb 12, 2024 and is designated Class I. Reason for recall: 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… The recall status is ongoing. Affected quantity: 461 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2024
- Initiation Date
- Feb 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 461 devices
Product Description
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Reason for Recall
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).
Distribution Pattern
Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1302-2024
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026