Recall Z-0211-2016 ยท MCX Catheter, Coronary, Atherectomy
Boston Scientific Corporation
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specializ
| Date | Nov 13, 2015 (initiated Oct 9, 2015) |
| Status | Terminated |
| Reason | Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture. |
| Root cause | Component change control |
| Action | The firm, Boston Scientific, sent an "Urgent Medical Device Recall Removal - Immediate Action Required" letter dated 10/9/2015. Letters were sent via overnight delivery (FedEx or other equivalent service). The letter stated the issue, identified affected devices, stated that further distribution or use of the devices should cease immediately, and affected product should be returned to Boston Scientific in accordance with the enclosed recall instructions. Complete and return the Recall Instructions via email: MapleGroveFieldActionCenter@bsci.com or Fax to: Field Action Center 1-866-213-1806. |
| Quantity | 955 single units (191 5-packs) |
| Distribution | Worldwide Distribution: US Distribution in the states of AZ, CA, DE, FL, GA, IL, LA, MD, MI, MN, NE, NY, PA, SC, TX, WA, and WI, and the countries of Belgium, Germany, Great Britain, Italy, Japan, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.