Z-0778-03

Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery...

Name: Z-0778-03 Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery...
Creator: Boston Scientific Scimed
Published: 2003-03-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-03-17 / Terminated / root cause: sterility

FDA source

Boston Scientific Scimed began a recall of Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401 on 2003-03-17. The reason FDA records is "A component within the manifold of the stent delivery systems was found to have pyrogen levels 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-0778-03
Status: Terminated
Initiated: 2003-03-17
Posted: 2003-04-22
Terminated: 2004-07-02
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401
Product code: MAF Stent, Coronary
Reason for recall: A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
Root cause tag: sterility
FDA root cause: Other
Action: Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots and return them.
Quantity in commerce: 7 Stent Systems
Distribution: Nationwide in the United States
Product codes and lots: Lot number 5350197

Product code MAF

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)