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Devices
Device Recall Guidant ENDOTAK SQ Array
Model / Serial
model 0048, serial numbers 200652 and 200655. model 0049, serial numbers 202864 thru 202900. model 0085, serial numbers 102087 thru 103287.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
nationwide and worldwide.
Product Description
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.
Manufacturer
Guidant Corporation
1 Event
Recall of Device Recall Guidant ENDOTAK SQ Array
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Manufacturer
Guidant Corporation
Manufacturer Address
Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
Source
USFDA
Language
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