Z-0711-03

Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250

Name: Z-0711-03 Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250
Creator: Boston Scientific Scimed
Published: 2003-03-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-03-20 / Terminated / root cause: packaging

FDA source

Boston Scientific Scimed began a recall of Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250 on 2003-03-20. The reason FDA records is "The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0711-03
Status: Terminated
Initiated: 2003-03-20
Posted: 2003-04-09
Terminated: 2004-07-02
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250
Product code: MAF Stent, Coronary
Reason for recall: The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were sent a recall letter dated March 20, 2003. The letter requested that the consignees discontinue use of stents from the affected lot and return them.
Quantity in commerce: 31 stents
Distribution: The product was shipped to 18 hospitals located nationwide in the United States. There are no US Government or foreign accounts.
Product codes and lots: Lot number 5140999

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)