Z-0351-03

Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47

Name: Z-0351-03 Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47
Creator: Medtronic Cardiac Surgery Technologies
Published: 2002-11-11
License: https://open.fda.gov/license/

Medtronic Cardiac Surgery Technologies / initiated 2002-11-11 / Terminated

FDA source

Medtronic Cardiac Surgery Technologies began a recall of Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47 on 2002-11-11. The reason FDA records is "The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0351-03
Status: Terminated
Initiated: 2002-11-11
Posted: 2015-06-25
Terminated: 2004-07-02
Recalling firm: Medtronic Cardiac Surgery Technologies
Product: Medtronic Cardioblate Radio Frequency Ablation Pen, model number 60811C47
Product code: 74
Reason for recall: The radio frequency ablation pens contained unreacted epoxy resin which was observed to leak out of the back-end of the device.
FDA 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 in commerce: 148 pens
Distribution: All of the consignees were in foreign countries in Europe, Asia and Latin America.
Product codes and lots: Lot number 2002080004

Product code 74

K013392Class IICardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation Generator, Model 60880Medtronic Vascular / cleared 2002-01-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)