—#73479

Product

Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K935997, K945379
Affected lot / code info: Lot # 11574626

Why it was recalled

Boston Scientific is initiating a voluntary recall of the Platinum Plus Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and the product may be labeled as a 180 CM long guidewire when the actual packaged device is a 260 CM long guidewire. There is no expected potential for injury to

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

A "Boston Scientific Urgent Voluntary Medical Device Recall or Correction - Immediate Action Required" letter dated 8/25/08 was sent to each affected account (To The Hospital Field Action Contact). The letter includes the customer steps for recall, a complete listing of all product batches/lots being recalled, the Reply Verification Tracking Form(s), and a return shipping label. Contact Boston Scientific Corporation at 1-763-494-1700 for assistance.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: USA: CA FL GA IL IN LA MN MO NJ NV NY OH PA TN TX UT WA WI and WV OUS: France, Germany, Great Britain, Italy, and the Netherlands.

Timeline

Recall initiated: 2008-08-25
Posted by FDA: 2008-10-02
Terminated: 2011-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73479. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.