Z-1211-2007

Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951

Name: Z-1211-2007 Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951
Creator: Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Published: 2007-07-16
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2007-07-16 / Terminated

FDA source

Abbott Vascular-Cardiac Therapies dba Guidant Corporation began a recall of Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951 on 2007-07-16. The reason FDA records is "The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1211-2007
Status: Terminated
Initiated: 2007-07-16
Posted: 2007-08-29
Terminated: 2011-06-14
Recalling firm: Abbott Vascular
Product: Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951
Product code: MAF Stent, Coronary
Reason for recall: The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.
FDA root cause: Other
Action: The firm initiated the recall on 07/16/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions to work with their local account representative to review their inventory, remove the recalled product, complete the Customer Reply form and return the recalled product to Abbott Vascular.
Quantity in commerce: 43 units
Distribution: Nationwide
Product codes and lots: Part number 1007848-15, lot number 7052951

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)