HOT AXIOS Stent System Recalled Due to Outer Sheath Detachment Risk
Boston Scientific is recalling HOT AXIOS Stent systems due to potential outer sheath detachment that can prevent proper stent expansion. This defect may require device replacement during the procedure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a reported mechanical defect that could impact patient safety by preventing proper stent expansion. No injuries or illnesses have been reported in the source text, qualifying this as a risk-of-harm product where injury has not yet been reported, per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling 118 units of the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 15mm, UPN M00553570) due to a reported defect affecting the outer sheath.
The outer sheath distal black tip may detach from the device during use. When the tip detaches, it can remain around the stent saddle, preventing proper stent expansion and requiring device exchange during the procedure.
The recalled units are distributed nationwide, including Puerto Rico, and to foreign locations. The affected lot numbers are: 32878539, 33336847, 33338446, 33775901, 33795273, 33900261, 33900262, 34076575, 34083270, 34172108, and 34172109.
The recalled product
- Product
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Stent
- Affected units
- 118
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- GTIN: 08714729976684 Lot Numbers: 32878539
- 33336847
- 33338446
- 33775901
- 33795273
- 33900261
- 33900262
- 34076575
- 34083270
- 34172108
- 34172109
Distribution
Part of a larger recall action
This product is one of 14 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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