Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Catalog # 1754, Material No. [In

FDA device recall Z-2365-2008 · posted 2008-09-21 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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

Action taken

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 Boston Scientific Corporation at 1-763-494-1700 for assistance.

Root cause

Process control

Status

Terminated

Product code

DQX

Quantity affected

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

Date initiated

2008-06-19

Date posted

2008-09-21

Date terminated

2010-10-13

Location

Maple Grove, MN

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