Z-0121-2007

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

Name: Z-0121-2007 Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an...
Creator: Enpath Medical, Inc
Published: 2006-07-18
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2006-07-18 / Terminated

FDA source

Enpath Medical, Inc began a recall of Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian IMD. Manufactured for Angel Medical... on 2006-07-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0121-2007
Status: Terminated
Initiated: 2006-07-18
Posted: 2006-11-09
Terminated: 2007-02-08
Recalling firm: Greatbatch Medical
Product: Angel 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.
Product code: DTB Permanent Pacemaker Electrode
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 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 notify customers.
Quantity in commerce: 20 Units
Distribution: CA, NJ, MN
Product codes and lots: Model LA-001, Lot # W38932

Product code DTB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)