Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian

FDA device recall Z-0121-2007 · posted 2006-11-09 · Terminated

Recall details

Recalling firm

Enpath Medical, Inc

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

DTB

Quantity affected

20 Units

Distribution

CA, NJ, MN

Date initiated

2006-07-18

Date posted

2006-11-09

Date terminated

2007-02-08

Location

Minneapolis, MN