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U.S. Department of Health and Human Services

Class 2 Device Recall AngelMed Guardian

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 Class 2 Device Recall AngelMed Guardiansee related information
Date Initiated by FirmJuly 18, 2006
Date PostedNovember 09, 2006
Recall Status1 Terminated 3 on February 08, 2007
Recall NumberZ-0121-2007
Recall Event ID 35983
Product Classification lead adaptor - Product Code DTB
ProductAngel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian IMD. Manufactured for Angel Medical Systems, Inc. 1 Shelia Drive, Tinton Falls, NJ; Part No. 0208-2100-001, provided to Angel Medical Systems for International Clinical Studies; Sterile/ EO, Single Use.
Code Information Model LA-001, Lot # W38932
Recalling Firm/
Manufacturer		 Enpath Medical, Inc
7452 W 78th St
Minneapolis MN 55439-2513
Manufacturer Reason
for Recall		The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.
FDA Determined
Cause 2		Other
ActionOn July 7th, Enpath determined that a recall of Model 501206 and 501214 Adapters should be initiated and contacted customer via telephone and formally notified via letter on July 10, 2006. On July 14th, Enpath determined that a recall of Model 501204, Model 501205 and Angel Medical Model LA-001 Adapters should be initiated and two more consignees were notified via telephone on July 17th and both formally notified via letter on July 18, 2006. Enpath requested that customers segregate and return any product from the lot numbers listed in the letter, cease distribution of these devices and notify customers.
Quantity in Commerce20 Units
DistributionCA, NJ, MN
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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