Recall Z-0120-2007 ยท DTB Permanent Pacemaker Electrode
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.
| Date | Nov 9, 2006 (initiated Jul 18, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 not |
| Quantity | 516 Leads |
| Distribution | CA, NJ, MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K870562 | DAIG PACEMAKER LEAD ADAPTOR Daig Corp., Mar 3, 1987 |