Z-0207-05

Medtronic CapSureFix Novus Lead Model 5076

Name: Z-0207-05 Medtronic CapSureFix Novus Lead Model 5076
Creator: Medtronic Inc. Cardiac Rhythm Managment
Published: 2004-10-20
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-10-20 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Inc. Cardiac Rhythm Managment began a recall of Medtronic CapSureFix Novus Lead Model 5076 on 2004-10-20. The reason FDA records is "A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0207-05
Status: Terminated
Initiated: 2004-10-20
Posted: 2004-11-17
Terminated: 2005-01-24
Recalling firm: Medtronic, Inc.
Product: Medtronic CapSureFix Novus Lead Model 5076.
Product code: DTA Tester, Pacemaker Electrode Function
Reason for recall: A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Letter of October 20, 2004, to direct customers, advised them to work with their respective Medtronic representatives to locate all leads and return them to Medtronic.
Quantity in commerce: 35 incorrectly labeled leads were distributed to customers.
Distribution: Leads were distributed to 21 consignees (hospitals/clinics) throughout the US.
Product codes and lots: Model 5076 45 cm leads (PJN631011V and PJN631012V)

Product code DTA

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)