Class I — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| 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. |
| 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… |
| Quantity | 7985 |
| Distribution | Worldwide Distribution - US (nationwide) including DC and Puerto Rico, and in the states of AK, AL, AR. AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY and the countries of Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hong Kong, Hunga… |
| Initiated | 2015-11-19 |
| Classified | 2015-12-18 |
| Terminated | 2017-02-23 |
| Recall number | Z-0392-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Boston Scientific Corporation (Z-0392-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72702/
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