—#88966

Product

Boston Scientific BLUE MAX" 20 Balloon Dilatation Catheter, UPN M001125420 (BMQ/7-4/5.8/40, 12-542), M001125630(BMQ/9-8/5.8/40, 12-563) Made in Ireland, Ballybrit Business Park, Galway, Ireland Recommended for Percutaneous Transluminal Angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

FDA product code: LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K071309
Affected lot / code info: 12936826, 12936827, 12936828, 12938360

Why it was recalled

Boston Scientific Corporation is conducting a Medical Device Recall Removal of specific lots/batches of the Blue Max and Ultrathin Diamond Balloon Dilatation Catheters. Boston Scientific has determined that, the sterile barrier in the catheter packaging (i.e. outer pouch side seal) of the affected products may be compromised. An undetected breach in sterility of the outer pouch may lead to contami

Root cause (FDA determination)

Packaging

Action the firm took

Two "URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED" letters dated February 17, 2010 and February 18, 2010 were sent to the customers. The letters described the Action Description, Affected Product and Recall Instructions. The customers should immediately discontinue use of and remove all affected recalled product from your inventory, segregate the product in a secure location for return to Boston Scientific, complete and return the enclosed Account Reply Verification Tracking Form (even if you do not have any product to return) -fax to: Customer Service Call Center (866) 213-1806, and package/ship the recalled product per instructions. Your local sales Representative can answer any questions that you may have regarding this Recall Removal. If you have any question, please contact (763) 494-7971.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA-AL, CA, FL, IL, MI, MS, NJ, NY, NC, PA, RI, SC, TN, VA, WI, and CANADA, JAPAN, GREAT BRITAIN, NETHERLANDS.

Timeline

Recall initiated: 2010-02-18
Posted by FDA: 2010-03-25
Terminated: 2011-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88966. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.