—#43970

Product

The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure.

FDA product code: LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K052038
PMA numbers: P950020
Affected lot / code info: Lot/Batch# EF0206 EF0300 EF5054 EF5062 EF5066 EF5113 EF5142 EF5187 5140F EF5188 EF5253 EFO017 EF0160 EF5069 EF5421 EF5547 EF5554

Why it was recalled

The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.

Root cause (FDA determination)

Other

Action the firm took

All affected direct accounts will be given notification by Overnight mail. A 100% of the total number of customer are to be contacted.

Recalling firm

Firm: Boston Scientific Corporation
Address: 3574 Ruffin Rd, San Diego, California 92123-2597

Distribution

Distribution pattern: Nationwide plus Argentina Austria Belgium Brunei Canada Chile China Colombia Czech Republic Denmark Finland France Germany Great Britain Hong Kong Hungary India Indonesia Ireland Israel Italy Latvia Lebanon Luxembourg Macau Malaysia Mexico Netherlands Norway Poland Portugal Puerto Rico Saudi Arabia. Singapore South Africa Spain Sweden Switzerland & Turkey

Timeline

Recall initiated: 2005-12-07
Posted by FDA: 2006-02-01
Terminated: 2007-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43970. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.