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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific BLUE MAX" 20 Balloon Dilatation Catheter

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  Class 2 Device Recall Boston Scientific BLUE MAX" 20 Balloon Dilatation Catheter see related information
Date Initiated by Firm February 18, 2010
Date Posted March 25, 2010
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-1211-2010
Recall Event ID 54669
510(K)Number K071309  
Product Classification catheter, angioplasty, peripheral, transluminal - Product Code LIT
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.
Code Information 12936826, 12936827, 12936828, 12938360
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact
763-494-1700
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Packaging
Action 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.
Quantity in Commerce 73
Distribution Worldwide distribution: USA-AL, CA, FL, IL, MI, MS, NJ, NY, NC, PA, RI, SC, TN, VA, WI, and CANADA, JAPAN, GREAT BRITAIN, NETHERLANDS.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LIT and Original Applicant = BOSTON SCIENTIFIC CORP.
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