Boston Scientific — Class I medical device recall Z-0392-2016
Terminated recall by Boston Scientific Corporation, reported 2015-12-30, distributed nationwide. Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientific has receive
| Recall number | Z-0392-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2015-11-19 |
| Classified | 2015-12-18 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2017-02-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HK, HU, IE, IT, LU, NO, PL, PT, SE, SI, SK, UA |
| Quantity | 7,985 |
| UPC / GTIN / UDI-DI | 74939277545110, 74939277745220, 74939277790220, 74939277845210 |
| Lot numbers | 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 and 460 more |
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 for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.