AXIOS Stent Delivery System Outer Sheath May Detach During Use
The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring 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: This is a risk-of-harm medical device with a mechanical defect that prevents the stent from expanding properly, which is critical to the device's intended function. No injuries or illnesses have been reported. The FDA Class II classification with mechanical failure and no reported harm places this at the High severity level per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling the AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 15mm, UPN: M00553670). The recall affects 309 units distributed nationwide, including Puerto Rico.
The recalled devices may have an outer sheath with a distal black tip that can detach from the device during use. If detachment occurs, the tip can remain around the stent saddle, preventing the stent from expanding properly. This results in a prolonged procedure and the need to exchange the affected device for a functioning one.
Patients who have had the AXIOS stent delivery system implanted should consult their healthcare provider if they experience signs of inadequate stent placement or complications. Healthcare providers using affected lot numbers should immediately discontinue use and contact Boston Scientific for guidance on device replacement and patient follow-up.
The recalled product
- Product
- AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
- Manufacturer
- Boston Scientific Corporation
- Hazard
- outer-sheath-detachment
- stent-expansion-failure
- device-malfunction
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: 08714729979333 Lot Numbers: 32901294
- 33223930
- 33328461
- 33413626
- 33459702
- 33686175
- 33686176
- 33766912
- 33814306
- 33825089
- 33860266
- 33920983
- 33920984
- 33930917
- 34020982
- 34020983
- 34111459
- 34111480
- 34111481
- 34135618
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27