Medical stent delivery system outer sheath component detachment prevents proper expansion
The HOT AXIOS Stent delivery system's outer sheath tip may detach during use, preventing proper stent expansion and requiring device exchange. Boston Scientific is recalling 1,102 units distributed nationwide.
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 an FDA Class II medical device recall. No hospitalizations or patient injuries have been reported in the source material. The recalled devices present a risk of harm—stent expansion failure that could result in failed medical procedures—but no actual injuries have been documented. Per severity guidelines, risk-of-harm products without reported injury receive a High rating.
Plain-English summary
The HOT AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm, UPN: M00553560) manufactured by Boston Scientific Corporation is being recalled. The device is designed for use in medical procedures requiring stent placement and delivery.
During use, the outer sheath's distal black tip can detach from the device. When this occurs, the detached tip may remain in contact with the stent saddle, preventing the stent from expanding properly. This device malfunction prevents successful completion of the intended medical procedure and requires the affected device to be exchanged for a functioning replacement.
Boston Scientific has recalled 1,102 units distributed nationwide, including Puerto Rico. Additional information regarding distribution to foreign locations will be provided separately. The recall encompasses devices from 87 identified lot numbers, documented in FDA records.
Healthcare providers should immediately review their inventory for devices matching the recalled lot numbers and quarantine any affected units. Devices should not be used and should be handled according to Boston Scientific's recall instructions. Healthcare providers should also identify any patients who may have received devices from the affected lots and consult with Boston Scientific regarding appropriate follow-up actions.
The recalled product
- Product
- HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,102
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: 08714729951100 Lot Numbers: 32865866
- 32874910
- 32875944
- 32876867
- 32876869
- 32876870
- 33195387
- 33195388
- 33195389
- 33195390
- 33209841
- 33209843
- 33215357
- 33283337
- 33284518
- 33284519
- 33288532
- 33288534
- 33301346
- 33301347
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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