FDA Medical Device Recalls (openFDA)
Medtronic Inc. Cardiac Rhythm Managment: Medtronic CapSureFix Novus Lead Model 5076.
- Recall number
- Z-0207-05
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Managment
- Product
- Medtronic CapSureFix Novus Lead Model 5076.
- Status
- Terminated
- Initiated
- 2004-10-20
- Posted
- 2004-11-17
- Terminated
- 2005-01-24
- Reason
- A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length.
- 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
- 35 incorrectly labeled leads were distributed to customers.
- Distribution
- Leads were distributed to 21 consignees (hospitals/clinics) throughout the US.
- Lot, serial or model codes
- Model 5076 45 cm leads (PJN631011V and PJN631012V)
- 510(k) numbers
- not on file
- PMA numbers
- ["P930039S009"]
- Product code
- DTA
- Firm FEI
- 2182208
- Firm city
- Fridley
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28