FDA Device recall Z-0392-2016

Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath…

FDA Device
Class I
terminated
Published 2015-12-30

On 2015-12-30 the FDA classified a Class I recall of Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath… by Boston Scientific, citing boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientific has received fourteen complaints for shaft separation, four for distal shaft sep….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0392-2016
Classification	Class I
Status	terminated
Initiated	2015-11-19
Published	2015-12-30
Last updated	2026-09-13 11:53 UTC
Company	Boston Scientific
Distribution	US

Product

Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 Guiding Sheath 6F, 45 cm, ST, CC H74939277645110 Guiding Sheath 6F, 45 cm, ST, TB H74939277645120 Guiding Sheath 6F, 45 cm, MP, CC H74939277645210 Guiding Sheath 6F, 45 cm, MP, TB H74939277645220 Guiding Sheath 6F, 65 cm, ST, CC H74939277665110 Guiding Sheath 6F, 65 cm, ST, TB H74939277665120 Guiding Sheath 6F, 90 cm, ST, CC H74939277690110 Guiding Sheath 6F, 90 cm, ST, TB H74939277690120 Guiding Sheath 6F, 90 cm, MP, CC H74939277690210 Guiding Sheath 6F, 90 cm, MP, TB H74939277690220 Guiding Sheath 7F, 45 cm, ST, CC H74939277745110 Guiding Sheath 7F, 45 cm, ST, TB H74939277745120 Guiding Sheath 7F, 45 cm, MP, CC H74939277745210 Guiding Sheath 7F, 45 cm, MP, TB H74939277745220 Guiding Sheath 7F, 65 cm, ST, CC H74939277765110 Guiding Sheath 7F, 65 cm, ST, TB H74939277765120 Guiding Sheath 7F, 90 cm, ST, CC H74939277790110 Guiding Sheath 7F, 90 cm, ST, TB H74939277790120 Guiding Sheath 7F, 90 cm, MP, CC H74939277790210 Guiding Sheath 7F, 90 cm, MP, TB H74939277790220 Guiding Sheath 8F, 45 cm, ST, CC H74939277845110 Guiding Sheath 8F, 45 cm, ST, TB H74939277845120 Guiding Sheath 8F, 45 cm, MP, CC H74939277845210 Guiding Sheath 8F, 65 cm, ST, CC H74939277865110 Guiding Sheath 8F, 65 cm, ST, TB H74939277865120 Guiding Sheath 8F, 90 cm, ST, CC H74939277890110 Guiding Sheath 8F, 90 cm, ST, TB H74939277890120 Product Usage: The Chariot Guiding Sheath is designed to perform as an introducer sheath for delivering interventional and diagnostic devices into the peripheral vasculature. The guiding sheath has a coiled shaft design and comes with a straight or preformed multipurpose tip shape. It is equipped with a cross-cut hemostatic valve or Tuohy-Borst adapter to prevent bleeding and a sidearm with a three-way stopcock to allow for flushing and introduction of contrast medium. It is packaged with a dilator to facilitate delivery over a guidewire. The guiding sheath can accommodate guidewires with diameters less than or equal to 0.038 in (0.97 mm). The outer surface of the guiding sheath has a hydrophilic coating from the distal tip to approximately 9 cm from the hub. The distal tip has a radiopaque marker band approximately 6 mm from the distal edge, to help with guiding sheath placement.

Reason

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.

Identifiers

code_info	Batch 17797683 17797684 17797685 17797686 17797687 17797688 17797689 17797690 17797691 17797692 17797693 17… Batch 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 17984693 17985812 17986420 17987381 17989008 17990047 17991170 17991321 17994529 17995087 17996706 17997093 17997095 17997242 17999337 17999936 18002533 18003369 18003765 18003862 18003942 18005013 18007740 18007952 18008205 18008324 18010176 18012336 18012757 18013142 18015270 18015790 18016778 18017840 18020685 18029579 18029913 18034289 18034502 180

code_info

Batch 17797683 17797684 17797685 17797686 17797687 17797688 17797689 17797690 17797691 17797692 17797693 17…

Batch 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 17984693 17985812 17986420 17987381 17989008 17990047 17991170 17991321 17994529 17995087 17996706 17997093 17997095 17997242 17999337 17999936 18002533 18003369 18003765 18003862 18003942 18005013 18007740 18007952 18008205 18008324 18010176 18012336 18012757 18013142 18015270 18015790 18016778 18017840 18020685 18029579 18029913 18034289 18034502 180

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0392-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.