Z-0862-03

MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13

Name: Z-0862-03 MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13
Creator: Guidant Corporation ACS
Published: 2003-05-07
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2003-05-07 / Terminated / root cause: sterility

FDA source

Guidant Corporation ACS began a recall of MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13 on 2003-05-07. The reason FDA records is "Sterility compromised". 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-0862-03
Status: Terminated
Initiated: 2003-05-07
Posted: 2003-05-22
Terminated: 2004-12-01
Recalling firm: Abbott Vascular
Product: MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13
Product code: MAF Stent, Coronary
Reason for recall: Sterility compromised.
Root cause tag: sterility
FDA root cause: Other
Action: The firm initially is notifying by letter dated May 6, 2003 and will plan visit follow-ups to collect quarantined product.
Quantity in commerce: 40
Distribution: NATIONWIDE
Product codes and lots: Lot 3021951

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)