Z-0032-04

Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm...

Name: Z-0032-04 Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm...
Creator: Boston Scientific Scimed
Published: 2003-08-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-08-20 / Terminated / root cause: sterility

FDA source

Boston Scientific Scimed began a recall of Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151 on 2003-08-20. The reason FDA records is "Some of the recalled catheters have a component that has levels of pyrogens above specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0032-04
Status: Terminated
Initiated: 2003-08-20
Posted: 2003-10-15
Terminated: 2005-10-24
Recalling firm: Boston Scientific Corporation
Product: Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Reason for recall: Some of the recalled catheters have a component that has levels of pyrogens above specification.
Root cause tag: sterility
FDA root cause: Other
Action: 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.
Quantity in commerce: 2 catheters
Distribution: The recalled products were distributed to consignees located nationwide in the United States.
Product codes and lots: Lot 5707453

Product code LOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)