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
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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
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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 |
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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.
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PMA Database | PMAs with Product Code = NIQ
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