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.
Hazard
A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.
What You Should Do
Remedy
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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Products
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
- Brand
- Guidant Corporation
- UPC
- model 0048, serial numbers 200652 and 200655. model 0049, serial numbers 202864 thru 202900. model 0085, serial numbers 102087 thru 103287.
Units Affected
710