Reported Apr 27, 2016 · Terminated
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is…
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 · 2 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
- Lot codes and dates
- BATCH
388 of 388 codes
129496130473139577141089141570142212145520145783148859149263153368153847154650154786155675155908156690156822158009158494158598159368159902160530161209162814162893162943163987164148166281166646168472169484169638170169170464170471171178171385171800172254172375172518172831173151173398173897173902174153174431174617174619174721174722174727174728174804174805175189
- BATCH
- Amount recalled
- 21,155 units
Where it was sold
Why it was recalled
Stop using this product now
Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient.
Using this product could cause serious injury, illness or death — stop using it now.
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