HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
FDA device recall Z-1036-2025 · posted 2025-01-29 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
- Action taken
- Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required Letter via Fedex Priority Overnight on December 20, 2024 to US consignees. Letter states reason for recall, health risk and action to take: This removal affects only the products listed in Attachment 1. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Contact your local Boston Scientific representative with any questions.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KNS
- Quantity affected
- 1102 units (OUS)
- Distribution
- Nationwide including Puerto Rico Foreign: To be provided
- Date initiated
- 2024-12-20
- Date posted
- 2025-01-29
- Location
- Marlborough, MA
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