AXIOS stents recalled over deployment and expansion problems during placement
Boston Scientific is recalling 557 AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 20mm x 10mm, after increased reports of stent deployment and expansion issues.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
The AXIOS Stent and Electrocautery-Enhanced Delivery System, 20mm x 10mm, is being recalled by Boston Scientific Corporation. The record gives the material number (UPN) as M00553660 in the product description and as M00553680 in the code field; both are reported here as printed.
The reason given in the enforcement record is increased reports of stent deployment and expansion issues. The record states the most common reasonably foreseeable outcome resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one, and that the most serious reasonably foreseeable outcome, in cases where the first flange is unable to deploy or expand, would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
The record lists 557 units under UDI-DI 8714729951179, with lot numbers recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide including Puerto Rico and a wide range of other countries listed in the record. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine affected stock and follow Boston Scientific's instructions.
The recalled product
- Product
- AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Stent
- Affected units
- 557
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)
- Material Number (UPN): M00553680
- UDI-DI: 8714729951179
- Lot Numbers: 35961006
- 35961007
- 35962524
- 35967379
- 35968520
- 35968521
- 35968597
- 35968598
- 35971077
- 35971078
- 35971079
- 35972100
- 35982272
- 35982273
- 35982274
- 35982275
- 35982276
- 35982277
Distribution
Part of a larger recall action
This product is one of 6 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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