TAXUS Express Paclitaxel-Eluting Over-The-Wire Coronary Stent Systems (2.75 x 12mm).
This recall has been terminated (originally issued July 20, 2004).
- Company
- Boston Scientific Scimed
- Recall Initiated
- July 1, 2004
- Posted
- July 20, 2004
- Terminated
- February 22, 2006
- Recall Number
- Z-1052-04
- Quantity
- 390
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.
Distribution
Nationwide and Canada
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.