FDA Device recall Z-1302-2024
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
- FDA Device
- Class I
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class I recall of Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 by Boston Scientific, citing 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. Thi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1302-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-02-12 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
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).
Identifiers
| code_info | GTIN 08714729992684, Batch Numbers: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 3…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1302-2024%22
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