[pending] HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00
Pending LLM rewrite. Source: FDA_DEVICE Z-1161-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
The recalled product
- Product
- HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Devices
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 (20)
- Material Number (UPN): M00553520
- UDI-DI: 8714729904540
- Lot Numbers: 36067957
- 36067958
- 36067959
- 36067960
- 36067961
- 36099410
- 36102139
- 36111317
- 36111318
- 36111319
- 36132439
- 36132800
- 36136724
- 36136725
- 36144054
- 36154527
- 36154528
- 36154529
Distribution
Distributed nationwide across the United States.
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