FDA Medical Device Recalls (openFDA)
Medtronic Cardiac Surgery Technologies: Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47
- Recall number
- Z-0351-03
- Recalling firm
- Medtronic Cardiac Surgery Technologies
- Product
- Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47
- Status
- Terminated
- Initiated
- 2002-11-11
- Posted
- not on file
- Terminated
- 2004-07-02
- Reason
- The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device.
- Root cause
- Other
- Action
- A letter dated November 11, 2002 was sent to the affected consignees who were requested to quarantine any unused pens for retrieval by Medtronic representatives.
- Quantity
- 148 pens
- Distribution
- All of the consignees were in foreign countries in Europe, Asia and Latin America.
- Lot, serial or model codes
- Lot number 2002080004
- 510(k) numbers
- ["K013392"]
- PMA numbers
- not on file
- Product code
- 74
- Firm FEI
- 3003368396
- Firm city
- Minneapolis
- 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