Recall Z-0392-2016 ยท DYB Introducer, Catheter
Boston Scientific Corporation
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,
| Date | Dec 18, 2015 (initiated Nov 19, 2015) |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent a Boston Scientific "Urgent Medical Device Recall Removal" letter dated November 19, 2015. The letter was addressed to Materials Manager /Field Action Contact. The letter described the problem and the product involved in the recall. Advised consignees to segregate and return affected product to Boston Scientific. Requested consignees to complete and return the "Recall Removal Reply Verification Tracking Form" to MapleGroveFieldActionCenter@bsci.com or fax to 1-866-213-1806. |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150186 | Chariot Guiding Sheath Boston Scientific Corp, Jun 5, 2015 |