Z-0859-06

Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of...

Name: Z-0859-06 Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of...
Creator: Covidien LP
Published: 2006-04-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-04-21 / Terminated

FDA source

Covidien LP began a recall of Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue on 2006-04-21. The reason FDA records is "Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0859-06
Status: Terminated
Initiated: 2006-04-21
Posted: 2006-05-10
Terminated: 2009-02-26
Recalling firm: Medtronic, Inc.
Product: Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode.
FDA root cause: Other
Action: Consignees were notified by telephone followed by a fax on 04/21/2006.
Quantity in commerce: 137 units
Distribution: Nationwide. AZ, CA, CO, CT, FL, GA, IL, MA, MI, MN, MO, MS, NC, NE, NJ, OH, OK, PA, TX, VA. Foreign distribution to Argentina, Canada, Chile, Costa Rica, France, Greece, Israel, Peru, Singapore.
Product codes and lots: Product Number: CTRF117 and CTRF220. Lot numbers: C4K101C thru C4K122C, C4K126C thru C4K133C, C4L134C thru C4L147C, C5A148C thru C5A158C, C5B159C thru C5B174C, C5C175C thru C5C191C, C5D192C thru C5D199C, C5E200C thru C5E213C, C5F214C thru C5F231C, C5G232C thru C5G235C, C5H236C thru C5H241C, C5I242C thru C5I246C, C5J247C thru C5J263C, C5K264C thru C5K272C, C5L273C thru C5L282C, C6A283C thru C6A286C.

Product code GEI

K984552Class IICool-Tip RF SystemRadionics, Inc. / cleared 1999-03-05

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)