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Terminated

Guidant ENDOTAK SQ Array models 0048, 0049, 0085. Subcutaneous Lead Array. Cardioversion/Defibrillation Lead. Guidant Corporation Cardiac Rhythm Management 4100 Hamline Avenue North, St. Paul, MN 55112-5798. Sterilized with gaseous ethylene oxide.

FDA Recall Z-1441-05 · Posted 2005-08-30

Recalling FirmGuidant Corporation
Recall StatusTerminated
Product CodeDYB
Date Initiated2005-06-13
Date Terminated2007-01-05
Product Quantity710

Reason for Recall

A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.

Firm Action

By Telephone, 6/13/2005. Guidant Sales Reps are to visit hospitals to remove any remaining inventory. Dear Hospital Administrator letter may be left with hospital to explain the removal of product.

Root Cause

Other

Distribution Pattern

nationwide and worldwide.

Official Source

View FDA Recall →

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

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