Recall Z-2364-2008 ยท DQX Wire, Guide, Catheter
Boston Scientific Corporation
Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531, Catalog # 1753, Material No. [Inner Pouch Label] H74917530. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston
| Date | Sep 21, 2008 (initiated Jun 19, 2008) |
| Status | Terminated |
| Reason | Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary Guidewires could be damaged in certain locations. This damage of the coating creates the potential for small particles of the PTFE coating to detach from the wi |
| Root cause | Process control |
| Action | An urgent Voluntary medical Device Recall or Correction - Immediate Action Required letter was sent to all affected customers. The letter describes the issue and clinical effects. A list of affected devices is attached to the letter. The customer is to cease use or distribution of affected product, and return it immediately to Boston Scientific. Return directions are provided in an attached document. A Reply Verification Tracking Form is to be completed and faxed back to Customer Service. If any product is being returned the completed form is to accompany the returned product. Contact |
| Quantity | 22,397 single units total (18,261 US, 4,136 OUS) |
| Distribution | AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Neth |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935997 | PLATINUM PLUS GUIDEWIRE Boston Scientific Corp, Jun 17, 1994 |