Reported Feb 5, 2025 · Ongoing
AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- AXIOS Stent and Electrocautery-
- Enhanced Delivery System 10mmx10mm UPNM00553640
- Lot codes and dates
- GTIN08714729904588
- Lot Numbers
328910423290045732908438332153583321535933216060332160623321966033219662332196633331596733315970333243983350019033520871335208723353765933538481335384843355900533813654338136553387124433948086339960383399603934004999341164693411647034251352342513533426161434261615342616163426337634263377342776893427769034297653342976573451295234526862
- Amount recalled
- 495 units US; 2 units(OUS)
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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