Reported Feb 5, 2025 · Ongoing
AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
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 20mmx10mm UPNM00553660
- Lot codes and dates
- GTIN08714729951179
- Lot Numbers
118 of 118 codes
329132583291458732914588329149513291934433161778331677223316772333167724331686963316869733217106332171073322392633223927332249493323346233234152332357203323572133242497332425603332486833333642335779013357790533661063336770433367704433677045336770463367704733677048336805233369748533767880337769353377693633778737337787383378575833785759337870223378702333787024337870253379661033804642340348963403489734034898340379533403795434037955340385843403879534047362340473643404736534074520
- Amount recalled
- 1399 units; 20 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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