Medtronic Inc. Cardiac Rhythm Managment Medtronic CapSureFix Novus Lead Model 5076. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic CapSureFix Novus Lead Model 5076.
Brand
Medtronic Inc. Cardiac Rhythm Managment
Lot Codes / Batch Numbers
Model 5076 45 cm leads (PJN631011V and PJN631012V)
Products Sold
Model 5076 45 cm leads (PJN631011V and PJN631012V)
Medtronic Inc. Cardiac Rhythm Managment is recalling Medtronic CapSureFix Novus Lead Model 5076. due to A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length.
Recommended Action
Per FDA guidance
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.
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 noticePage updated: Jan 10, 2026