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U.S. Department of Health and Human Services

Class 2 Device Recall Enpath

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 Class 2 Device Recall Enpathsee related information
Date Initiated by FirmJuly 18, 2006
Date PostedNovember 09, 2006
Recall Status1 Terminated 3 on February 08, 2007
Recall NumberZ-0120-2007
Recall Event ID 35983
510(K)NumberK870562 
Product Classification pacemaker lead adapter - Product Code DTB
ProductEnpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and 501214. All labeled Sterile, EO, mail: Enpath Medical, Inc. Lead Technologies Division, Minneapolis, MN 55439 USA.
Code Information Model 501204 - Lot W35696, Model 501205 - Lot # W39157, Model 501206 - Lot #s W38997, W39457, W39156, W39389, W39687, W39665. Model 501214 - Lot #s W38961, W39457, W39671, W39763, W40053, W40704, W41307.
Recalling Firm/
Manufacturer		 Enpath Medical, Inc
7452 W 78th St
Minneapolis MN 55439-2513
Manufacturer Reason
for Recall		Enpath Lead Adapters: 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 Commerce516 Leads
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.
510(K) Database510(K)s with Product Code = DTB
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