Medtronic CapSureFix Novus Lead Model 5076.
FDA device recall Z-0207-05 · posted 2004-11-17 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Managment
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DTA
- Quantity affected
- 35 incorrectly labeled leads were distributed to customers.
- Distribution
- Leads were distributed to 21 consignees (hospitals/clinics) throughout the US.
- Date initiated
- 2004-10-20
- Date posted
- 2004-11-17
- Date terminated
- 2005-01-24
- Location
- Fridley, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.