Z-0563-05

Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1

Name: Z-0563-05 Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1
Creator: TissueLink Medical, Inc.
Published: 2005-02-07
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2005-02-07 / Terminated

FDA source

TissueLink Medical, Inc. began a recall of Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1 on 2005-02-07. The reason FDA records is "The tip may separate from the device and render it unusable". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0563-05
Status: Terminated
Initiated: 2005-02-07
Posted: 2005-02-25
Terminated: 2005-04-20
Recalling firm: Medtronic Navigation, Inc
Product: Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The tip may separate from the device and render it unusable
FDA root cause: Other
Action: TissueLink notified consignees by Federal Express Letter from 2/7/05 to 2/8/05. Users are requested to return devices in inventory.
Quantity in commerce: 588 units
Distribution: AZ, CA, CO, CT, DE, IL, FL, KS, KY, OH, MA, MD MO,NC, NY, PA, RI, SC, TN,TX, VA Foreign: Italy, Turkey, Egypt, Spain, Peru, Portugal, Australia, Netherlands Government: VA Medical Center 508 Fulton Street Durham, NC 27005 VA Medical Center- 7400 Merton Minter Blvd San Antonio, TX 78229 VA Medical Center- Pittsburgh University C Pittsburgh, PA 15240
Product codes and lots: Lot Number: TL033300

Product code GEI

K014260Class IITissuelink Solid Cylinder Monopolar DeviceTissuelink Medical, Inc. / cleared 2002-03-27

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)