AXIOS Stent Delivery System: Detaching Outer Sheath May Prevent Stent Expansion
Boston Scientific is recalling 1,144 AXIOS Stent Delivery System units because the outer sheath's distal black tip can detach. If this occurs, the tip may remain around the stent saddle and prevent proper stent expansion, requiring device exchange.
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: This is an FDA Class II medical device recall involving a mechanical defect in a stent delivery system. The outer sheath detachment is a real, observed malfunction that prevents proper device function. No injuries or deaths have been reported, placing this in the High severity category for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling specific lots of the AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm, UPN: M00553650) due to a potential defect. Approximately 1,144 units have been distributed nationwide in the United States, including Puerto Rico, and 60 units internationally.
The outer sheath's distal black tip can detach from the device during use. If this occurs, the separated tip may remain around the stent saddle, preventing the stent from expanding properly during the procedure.
When this defect occurs, physicians must extend the procedure to remove the malfunctioning device and exchange it for a new one. Healthcare facilities that may have received devices from the affected lot numbers should verify their inventory and follow Boston Scientific's instructions regarding management and replacement of recalled units.
The recalled product
- Product
- AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
- Manufacturer
- Boston Scientific Corporation
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)
- GTIN: 08714729904595 Lot Numbers: 32891503
- 32946481
- 32966087
- 32976911
- 32986912
- 32986913
- 32986914
- 32996152
- 33004776
- 33004777
- 33004779
- 33008425
- 33527176
- 33547873
- 33559652
- 33562171
- 33568700
- 33568705
- 33568709
- 33580106
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 →- 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
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12
- HighNeuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
FDA (Devices) · 2026-08-12