Boston Scientific Recalls Flextome Cutting Balloons

In December 2005, Boston Scientific recalled the company's Flextome Cutting Balloon Monorail Delivery System, which is an angioplasty balloon with microsurgical blades attached to its sides.

These devices are being recalled because the catheter shaft that is used to place the balloon in the artery may fracture when the device is being withdrawn from the patient. If that happens, the procedure may be prolonged or the patient may require additional surgery to remove the piece that has broken off. The company says that they have received reports of eight patients who were affected by this problem. Three of them needed additional surgery.

The recall does not affect patients who have already received treatment with this device because the potential problem occurs during the procedure.
Boston Scientific says that these devices should not be used and should be returned to the company. To arrange for return of the recalled product, contact Boston Scientific at 1-800-811-3211.

Category:

News & Politics

Tags:

• Boston
• Scientific
• Flextome
• Cutting
• Balloon
• Monorail
• Delivery
• System
• Recall
• Angioplasty
• FDA
• Patient
• Safety