Reported Mar 28, 2018 · Terminated

SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600

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?

  • SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Lot codes and dates
  • 68 of 68 codes

    • 21071349
    • 21186199
    • 21264281
    • 21338493
    • 21072506
    • 21186874
    • 21264826
    • 21339969
    • 21097205
    • 21189216
    • 21268628
    • 21346857
    • 21099913
    • 21192332
    • 21269880
    • 21348369
    • 21101809
    • 21194784
    • 21275009
    • 21348655
    • 21104860
    • 21196427
    • 21279183
    • 21351508
    • 21106212
    • 21196815
    • 21280166
    • 21354138
    • 21111667
    • 21197475
    • 21282419
    • 21355128
    • 21112353
    • 21198355
    • 21284302
    • 21356067
    • 21120166
    • 21201164
    • 21285174
    • 21359495
    • 21121467
    • 21203598
    • 21285708
    • 21360857
    • 21125598
    • 21204762
    • 21287283
    • 21361914
    • 21129863
    • 21207916
    • 21291325
    • 21366469
    • 21134585
    • 21210287
    • 21291903
    • 21368941
    • 21136699
    • 21212151
    • 21295990
    • 21372468
    21
    • 150144
    • 21218379
    • 21305351
    • 21377827
    • 21150932
    • 21220903
    • 21307321
    • 21380698
    • 21156170
    • 21221247
    • 21308963
    • 21381638
    • 21159396
    • 21226282
    • 21310860
    • 21385327
    • 211
    • 60496
    • 21227147
    • 21311361
    • 21387164
    • 21163684
    • 21233949
    • 21313025
    • 21387745
    2
    • 1164861
    • 21235402
    • 21313392
    • 21391319
    • 21165772
    • 21237929
    • 21315518
    • 21393249
    • 211
    • 68729
    • 21240546
    • 21316968
    • 21393900
    • 21169977
    • 21241587
    • 21317017
    • 21395015
    • 21170814
    • 21245984
    • 21322828
    • 21395016
    • 21174026
    • 21246770
    • 21324197
    • 21401047
    • 211
    • 75845
    • 21249893
    • 21324851
    • 21401048
    • 211
    • 76842
    • 21251968
    • 21329021
    • 21401049
    • 21180343
    • 21253001
    • 21329708
    • 21413940
    • 21181253
    • 21254244
    • 21332229
    • 21414750
    • 21181677
    • 21257214
    • 21334848
    • 21420240
    • 21186002
    • 21260915
    • 21335787
Amount recalled
5026

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide

Why it was recalled

Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 13, 2019 · Data as of Sep 19, 5:28 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.