Enpath Medical, Inc Enpath 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Enpath 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.
Brand
Enpath Medical, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Enpath Medical, Inc is recalling Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, due to Enpath Lead Adapters: The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, MN, NJ
Page updated: Jan 10, 2026