AXIOS Stent Delivery System recalled due to distal sheath detachment
Boston Scientific is recalling 38 units of AXIOS Stent and Delivery System (15mmx10mm) because the outer sheath's distal tip may detach, preventing proper stent expansion and requiring device replacement.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II medical device recall with no reported illnesses or injuries in the source. The hazard is device malfunction (component detachment preventing proper stent expansion). Per the rubric, recalls without reported adverse outcomes are at most Score 3.
Plain-English summary
Boston Scientific Corporation is recalling 38 units of the AXIOS Stent and Delivery System (15mmx10mm, UPN: M00553750) in a Class II recall due to a potential defect affecting device functionality.
The outer sheath's distal black tip may detach from the device during use. When detachment occurs, the tip can remain around the stent saddle, preventing the stent from expanding properly.
If a stent fails to expand as intended, the medical procedure must be prolonged and the device must be exchanged for a new one. The affected units are identified by lot numbers 33740402, 33785754, and 34037422. The recall applies to products distributed nationwide, including Puerto Rico.
The recalled product
- Product
- AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 38
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 (3)
- GTIN: 08714729904632 Lot Numbers: 33740402
- 33785754
- 34037422
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.
See all 14 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
Similar recalls
- SevereBoston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment
FDA (Devices) · 2021-01-13
- HighBoston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment Risk
FDA (Devices) · 2021-01-13
- CriticalAXIOS stents recalled over deployment and expansion problems during placement
FDA (Devices) · 2026-02-11
- SevereBoston Scientific Recalls AXIOS Stent Delivery Systems Due to Fitting Detachment Risk
FDA (Devices) · 2021-01-13
- SevereBoston Scientific Recalls Hot AXIOS Stent Delivery System Due to Fitting Detachment
FDA (Devices) · 2021-01-13
- HighBoston Scientific Recalls Hot AXIOS Stent Delivery Systems Due to Fitting Detachment
FDA (Devices) · 2021-01-13