Recall Z-1302-2024— Boston Scientific Corporation
Class I · Ongoing
Class I FDA medical device recall by Boston Scientific Corporation, initiated 2024-02-12. It names one FDA 510(k) clearance: K223824. 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)..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-02-12
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.