Outer Sheath Detachment in HOT AXIOS Stent Delivery System
Boston Scientific's HOT AXIOS stent delivery system may have an outer sheath that detaches and prevents proper stent expansion. The defective tip can remain around the stent, requiring device exchange during the procedure.
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: FDA Class II medical device with reported defect preventing proper stent expansion. No illnesses or injuries reported, but constitutes a risk-of-harm scenario for a critical cardiovascular device.
Plain-English summary
Boston Scientific Corporation is recalling HOT AXIOS Stent and Electrocautery-Enhanced Delivery System units (6mm x 8mm, UPN M00553520) due to a reported defect in the outer sheath.
The outer sheath distal black tip can detach from the device and remain positioned around the stent saddle. This detachment prevents proper stent expansion, which requires the procedure to be extended and the device to be exchanged for a new one. The recall affects units distributed nationwide, including Puerto Rico, with specific lot numbers provided by the manufacturer.
Patients who have received this device or healthcare providers with inventory of affected lot numbers should contact Boston Scientific Corporation with questions. Patients experiencing complications related to stent expansion should consult with their healthcare provider.
The recalled product
- Product
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 263
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: 08714729904540 Lot Numbers: 33336402
- 33336404
- 33336405
- 33336411
- 33392916
- 33392917
- 33393302
- 33411607
- 33437479
- 33548501
- 33577903
- 33704371
- 33712822
- 33986537
- 34017087
- 34017088
- 34017089
- 34028458
- 34065579
- 34065660
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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Similar recalls
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