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Ace Percutaneous Transluminal Coronary Angioplasty (PTCA)… recallZ-0031-04 · Boston Scientific Scimed · initiated Aug 20, 2003

Terminated All recalls posted in October 2003

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 Scimed 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

Some of the recalled catheters have a component that has levels of pyrogens above specification.

FDA root cause category: Other

What the company is doing

Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them.

Recall details

Recall number
Z-0031-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 20, 2003
Posted by the FDA
Oct 15, 2003
Recalling firm
Boston Scientific Scimed
Quantity
6 catheters
Product code
LOX
FDA submissions
P860019
Distribution
The recalled products were distributed to consignees located nationwide in the United States.

Product description

Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051

Code information (models, lots, serial numbers)

Lots 5685024 and 5685027

Other devices under the same FDA submission

105 devices cleared under P860019 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 27231).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page