Z-1123-03

Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235

Name: Z-1123-03 Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235
Creator: Boston Scientific Scimed
Published: 2003-07-16
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-07-16 / Terminated

FDA source

Boston Scientific Scimed began a recall of Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235 on 2003-07-16. The reason FDA records is "There is an Increased potential for broken struts of the stents". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1123-03
Status: Terminated
Initiated: 2003-07-16
Posted: 2003-08-12
Terminated: 2006-12-28
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235
Product code: MAF Stent, Coronary
Reason for recall: There is an Increased potential for broken struts of the stents.
FDA root cause: Other
Action: Consignees were sent a recall letter dated July 16, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Quantity in commerce: 17 stent systems
Distribution: The products were shipped to consignees located nationwide in the United States.
Product codes and lots: Lot 5570485

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)