Z-1037-2025Class II
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Boston Scientific Corporation / initiated 2024-12-20 / Open, Classified / root cause: manufacturing process
Boston Scientific Corporation began a recall of HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1037-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Boston Scientific Corporation
- Product
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
- Product code
- KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- 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.
- Quantity in commerce
- 118 units (OUS)
- Distribution
- Nationwide including Puerto Rico Foreign: To be provided
- Product codes and lots
- GTIN: 08714729976684 Lot Numbers: 32878539, 33336847, 33338446, 33775901, 33795273, 33900261, 33900262, 34076575, 34083270, 34172108, 34172109
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1024-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1025-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1026-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1027-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1028-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1029-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1030-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1031-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1032-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1033-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1034-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1035-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1036-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1037-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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