FDA Device Recall Z-0031-2009: Boston Scientific Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0031-2009.

Recall Res Number

Z-0031-2009

Recalling Firm / Manufacturer

Boston Scientific Corporation

FEI Number

3002095335

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-08-25

Date Posted

2008-10-02

Date Terminated

2011-12-10

Product Code

DQX

Event Number

49462

Product Quantity

Product Description Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, 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.

Reason for Recall 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

Action Details 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.

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.

Code Information / Serial Numbers Lot # 11574628

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Medical Device Recall: Z-0031-2009

Recall Parameters & Description

Related Establishments / Registrations

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