Medtronic CapSureFix Novus Lead Model 5076.
FDA Recall Z-0207-05 · Posted 2004-11-17
Recalling FirmMedtronic Inc. Cardiac Rhythm Managment
Recall StatusTerminated
Product CodeDTA
Date Initiated2004-10-20
Date Terminated2005-01-24
Product Quantity35 incorrectly labeled leads were distributed to customers.
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Leads were distributed to 21 consignees (hospitals/clinics) throughout the US.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.