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The Peripheral Cutting Balloon Device small Monorail… recallZ-0410-06 · Boston Scientific Corporation · initiated Dec 7, 2005

Terminated All recalls posted in February 2006

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Other

What the company is doing

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

Recall details

Recall number
Z-0410-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 7, 2005
Posted by the FDA
Feb 1, 2006
Recalling firm
Boston Scientific Corporation
Quantity
individual qty in US:376, Worldwide distribution pending.
Product code
LIT
FDA submissions
K052038, P950020
Distribution
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

Product description

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.

Code information (models, lots, serial numbers)

Lot/Batch# EF0206 EF0300 EF5054 EF5062 EF5066 EF5113 EF5142 EF5187 5140F EF5188 EF5253 EFO017 EF0160 EF5069 EF5421 EF5547 EF5554

Other devices under the same FDA submission

37 devices cleared under K052038, P950020 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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