This morning Boston Scientific announced a voluntary recall of its Flextome cutting balloon angioplasty devices.
The firm said it is initiating the recall because it has determined through complaints and testing that the distal shaft of the catheter may separate during withdrawal of the device. A shaft separation may prolong the procedure or require additional surgery, according to the Natick, MA-based Boston Scientific.
The company stressed that the action does not affect patients who have already received treatment with the recalled devices because the potential problem occurs during the procedure. The total number of devices involved in the recall is estimated at 40,000, Boston Scientific said.
The firm said it is working with the FDA and is notifying officials in other countries of the recall. To arrange for the return of the affected product, Boston Scientific can be contacted at 800-811-3211.
By AuntMinnie.com staff writers
December 8, 2005
Related Reading
Guidant to hold discussions with Boston Scientific, December 8, 2005
Boston Scientific offers to buy Guidant, December 5, 2005
Boston Scientific inks Affinergy collaboration deal, November 1, 2005
Boston Scientific opens European distribution center, October 27, 2005
Boston Scientific creates Taxus assurance program, October 13, 2005
Copyright © 2005 AuntMinnie.com
