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U.S. Department of Health and Human Services

Class 1 Device Recall Taxus

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  Class 1 Device Recall Taxus see related information
Date Initiated by Firm July 01, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on February 22, 2006
Recall Number Z-1052-04
Recall Event ID 29479
PMA Number P030025 
Product Classification Coronary Drug-Eluting Stent - Product Code NIQ
Product TAXUS Express Paclitaxel-Eluting Over-The-Wire Coronary Stent Systems (2.75 x 12mm).
Code Information No 2.25 mm lots were distributed in U.S. U.S Distributed - 2.5 mm - Lot number/Exp. Date: 6171851 May-04 U.S Distributed - 2.75 mm - Lot number/Exp. Date: 6294706 Jun-04 U.S Distributed - 3.0 mm - Lot number/Exp. Date: 6337153 Jul-04 6422009 Aug-04 6555155 Sep-04 6271481 Jun-04 U.S Distributed - 3.5mm - Lot number/Exp. Date: 6111269 Apr-04 No 4.0 mm lots distributed in U.S. No TAXUS OTW were sold outside the U.S.       
Recalling Firm/
Manufacturer		 Boston Scientific Scimed
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Michelle Gudith
763-494-1194
Manufacturer Reason
for Recall		 On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.
FDA Determined
Cause 2		 Other
Action July 2 and 16, 2004 recall letters were sent to user accounts, such as Hospitals and clinics of the need to recall TAXUS Express2 Paclitaxel-Eluting and Express 2 Coronary Stent Systems. Recall was due to characteristics in the delivery catheters that had the potential to impede balloon deflation during a coronary angioplasty procedure, a condition known as focal neckdown. An additional 38 lots were added to the recall on August 5, 2004, for the same reason.
Quantity in Commerce 390
Distribution Nationwide and Canada
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.
PMA Database PMAs with Product Code = NIQ and Original Applicant = Boston Scientific Corp.
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