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.
This recall has been terminated (originally issued August 30, 2005).
- Company
- Guidant Corporation
- Recall Initiated
- June 13, 2005
- Posted
- August 30, 2005
- Terminated
- January 5, 2007
- Recall Number
- Z-1441-05
- Quantity
- 710
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
Distribution
nationwide and worldwide.
Lot / Code Info
model 0048, serial numbers 200652 and 200655. model 0049, serial numbers 202864 thru 202900. model 0085, serial numbers 102087 thru 103287.
Root Cause
Other
Action Taken
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.
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