Stent system outer sheath may detach, preventing proper expansion
Boston Scientific's HOT AXIOS Stent has a reported defect where the outer sheath distal black tip can detach, preventing proper stent expansion and 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 recall involving a documented device malfunction that prevents proper stent expansion. However, the source contains no reports of actual patient injury or hospitalization. The defect represents a risk-of-harm scenario with procedural consequences but lacks confirmed adverse outcomes, placing it in the High category per the rubric.
Plain-English summary
Boston Scientific Corporation has recalled the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm, UPN M00553550). The device has a reported defect affecting approximately 1,530 units distributed nationwide in the United States and Puerto Rico.
The outer sheath of the device has a distal black tip that can detach during use. When detachment occurs, the tip can remain around the stent saddle, preventing proper stent expansion. This defect requires exchanging the affected device for a new one and prolongs the clinical procedure.
The recalled product is identified by GTIN 08714729904571 and multiple specific lot numbers listed in the FDA recall notice. Hospitals and healthcare facilities that have stocked this product should review their inventory against the affected lot numbers.
Patients and healthcare providers should contact Boston Scientific with questions about affected units. Any adverse events or device malfunctions should be reported to the FDA's MedWatch program.
The recalled product
- Product
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
- Manufacturer
- Boston Scientific Corporation
- Hazard
- component-detachment
- improper-expansion
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: 08714729904571 Lot Numbers: 32868212
- 32947950
- 32998424
- 32998425
- 33177074
- 33177075
- 33177077
- 33185872
- 33185873
- 33185874
- 33185875
- 33185877
- 33187647
- 33187648
- 33195395
- 33195397
- 33209120
- 33209135
- 33209138
- 33209139
Distribution
Distributed nationwide across the United States.
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