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U.S. Department of Health and Human Services

Class 2 Device Recall Guidant ENDOTAK SQ Array

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 Class 2 Device Recall Guidant ENDOTAK SQ Arraysee related information
Date Initiated by FirmJune 13, 2005
Date PostedAugust 30, 2005
Recall Status1 Terminated 3 on January 05, 2007
Recall NumberZ-1441-05
Recall Event ID 32395
PMA NumberP910073/S3 P910077/S2 P910077S032 
Product Classification Introducer, Catheter - Product Code DYB
ProductGuidant 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.
Code Information model 0048, serial numbers 200652 and 200655.  model 0049, serial numbers 202864 thru 202900. model 0085, serial numbers 102087 thru 103287.
Recalling Firm/
Manufacturer
Guidant Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information ContactGuidant Technical Services
800-227-3422
Manufacturer 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.
FDA Determined
Cause 2
Other
ActionBy 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.
Quantity in Commerce710
Distributionnationwide and worldwide.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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