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Terminated

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

FDA Recall Z-1211-2007 · Posted 2007-08-29

Recalling FirmAbbott Vascular-Cardiac Therapies dba Guidant Corporation
Recall StatusTerminated
Product CodeMAF
Date Initiated2007-07-16
Date Terminated2011-06-14
Product Quantity43 units

Reason for Recall

The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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