Boston Scientific HOT AXIOS Stent Delivery Systems Recalled for Component Detachment
Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.
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 a reported device malfunction preventing proper stent expansion, creating risk of harm to patients. No illnesses, injuries, or deaths have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Boston Scientific Corporation is recalling HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems (10mmx10mm, UPN M00553540) due to a reported defect in the outer sheath. The distal black tip can detach and remain around the stent saddle, preventing proper stent expansion. When this occurs, the device must be exchanged for a new one, extending the medical procedure.
The recall affects 519 units distributed nationwide, including Puerto Rico and internationally. Multiple lot numbers are involved as documented by the FDA.
Healthcare providers and patients who have this device should contact Boston Scientific for further instructions. Individuals who received this device during a procedure should consult their healthcare provider if concerned about the defect.
The recalled product
- Product
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 519
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: 08714729904564 Lot Numbers: 33169261
- 33169263
- 33209127
- 33243075
- 33243077
- 33243856
- 33255964
- 33488328
- 33787031
- 33787032
- 33853395
- 33882221
- 33882222
- 33899656
- 33909280
- 33979053
- 33979055
- 34027245
- 34027246
- 34035523
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.
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