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Terminated

RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.

FDA Recall Z-0749-2010 · Posted 2010-01-29

Recall StatusTerminated
Product CodeNIM
Date Initiated2009-10-01
Date Terminated2011-09-27
Product Quantity22 units

Reason for Recall

The recall was initiated after Abbott Vascular discovered, through internal testing, that the affected lot may not meet our quality specifications for catheter shaft tensile strength.

Firm Action

Abbott Vascular's Sales Representatives initiated customer contact with the identified consignees beginning October 1, 2009 . They provided the consignees with a recall letter with attached fax-back effectiveness check form. The recall letter instructed the consignees to work with their local account representative to review their inventory, complete the attached recall effectiveness check form and return identified products to Abbott Vascular. For further information, contact Abbott Vascular Customer Service at 1-800-227-9902.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

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

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