Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (
FDA device recall Z-0392-2016 · posted 2015-12-18 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 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,
- Date initiated
- 2015-11-19
- Date posted
- 2015-12-18
- Date terminated
- 2017-02-23
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Chariot Guiding Sheath (K150186) | Boston Scientific Corp | 2015-06-05 |