Reported Dec 30, 2015 · Terminated

Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide

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, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide

29 of 29 products

Products covered by this recall
Model / numberProduct as published
H74939277545110Guiding Sheath 5F, 45 cm, ST, CC
H74939277545210Guiding Sheath 5F, 45 cm, MP, CC
H74939277645110Guiding Sheath 6F, 45 cm, ST, CC
H74939277645120Guiding Sheath 6F, 45 cm, ST, TB
H74939277645210Guiding Sheath 6F, 45 cm, MP, CC
H74939277645220Guiding Sheath 6F, 45 cm, MP, TB
H74939277665110Guiding Sheath 6F, 65 cm, ST, CC
H74939277665120Guiding Sheath 6F, 65 cm, ST, TB
H74939277690110Guiding Sheath 6F, 90 cm, ST, CC
H74939277690120Guiding Sheath 6F, 90 cm, ST, TB
H74939277690210Guiding Sheath 6F, 90 cm, MP, CC
H74939277690220Guiding Sheath 6F, 90 cm, MP, TB
H74939277745110Guiding Sheath 7F, 45 cm, ST, CC
H74939277745120Guiding Sheath 7F, 45 cm, ST, TB
H74939277745210Guiding Sheath 7F, 45 cm, MP, CC
H74939277745220Guiding Sheath 7F, 45 cm, MP, TB
H74939277765110Guiding Sheath 7F, 65 cm, ST, CC
H74939277765120Guiding Sheath 7F, 65 cm, ST, TB
H74939277790110Guiding Sheath 7F, 90 cm, ST, CC
H74939277790120Guiding Sheath 7F, 90 cm, ST, TB
Lot codes and dates
  • Batch

    637 of 637 codes

    • 17797683
    • 17797684
    • 17797685
    • 17797686
    • 17797687
    • 17797688
    • 17797689
    • 17797690
    • 17797691
    • 17797692
    • 17797693
    • 17797694
    • 17797695
    • 17797696
    • 17797697
    • 17798268
    • 17798269
    • 17798270
    • 17798271
    • 17798272
    • 17798273
    • 17806530
    • 17829972
    • 17829976
    • 17830219
    • 17839346
    • 17839347
    • 17839350
    • 17866538
    • 17866881
    • 17866882
    • 17872044
    • 17872045
    • 17915368
    • 17915369
    • 17940916
    • 17941111
    • 17943786
    • 17945064
    • 17945224
    • 17946351
    • 17949277
    • 17950404
    • 17951572
    • 17952749
    • 17953534
    • 17958093
    • 17958489
    • 17961473
    • 17962740
    • 17966591
    • 17971123
    • 17972092
    • 17972761
    • 17976335
    • 17977575
    • 17978575
    • 17981064
    • 17983006
    • 17983027
Amount recalled
7985

Where it was sold

Why it was recalled

Stop using this product now

Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientific has received fourteen complaints for shaft separation, four for distal shaft separation. The most severe outcome of this failure is embolism of device fragments.

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 Feb 23, 2017 · Data as of Sep 19, 6:02 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.