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

    • 129496
    • 130473
    • 139577
    • 141089
    • 141570
    • 142212
    • 145520
    • 145783
    • 148859
    • 149263
    • 153368
    • 153847
    • 154650
    • 154786
    • 155675
    • 155908
    • 156690
    • 156822
    • 158009
    • 158494
    • 158598
    • 159368
    • 159902
    • 160530
    • 161209
    • 162814
    • 162893
    • 162943
    • 163987
    • 164148
    • 166281
    • 166646
    • 168472
    • 169484
    • 169638
    • 170169
    • 170464
    • 170471
    • 171178
    • 171385
    • 171800
    • 172254
    • 172375
    • 172518
    • 172831
    • 173151
    • 173398
    • 173897
    • 173902
    • 174153
    • 174431
    • 174617
    • 174619
    • 174721
    • 174722
    • 174727
    • 174728
    • 174804
    • 174805
    • 175189
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 11, 2017 · Data as of Sep 19, 5:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.