Z-0954-2011

Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien...

Name: Z-0954-2011 Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien...
Creator: Covidien LP
Published: 2010-12-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-12-08 / Terminated / root cause: design

FDA source

Covidien LP began a recall of Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP... on 2010-12-08. The reason FDA records is "During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0954-2011
Status: Terminated
Initiated: 2010-12-08
Posted: 2011-01-25
Terminated: 2012-03-27
Recalling firm: Medtronic, Inc.
Product: Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301 Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Covidien, sent a "URGENT: PRODUCT RECALL" letter dated December 6, 2010, to the customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to remove product from inventory, immediately quarantine the product and return any remaining stock of the lots listed to: Covidien Energy-based devices, Attention: R82, Building 4/Receiving, 5920 Longbow Drive, Boulder, CO 80301. The customers were also instructed to complete and return the Customer Response Form immediately via mail (in the envelope provided) or fax to (303) 516-8307. To return any identified product for credit or replacement, contact Customer Service at 1-800-722-8772 Option 1. Should you have any medical questions concerning this recall, please contact your local sales representative or the Covidien Clinical information Hotline at (800) 255-8522 (option 1).
Quantity in commerce: 25,009 units
Distribution: Worldwide distribution: USA and countries including: Australia, Canada, France, Germany, Japan, Puerto Rico, Singapore, and Uruguay.
Product codes and lots: Lot No.: 188856, 190048, 190107, and 190307 through 193333 (88 lots).

Product code GEI

K092879Class IILigasure 5Mm Blunt Tip Laparoscopic Sealer-DividerValleylab / cleared 2009-10-16

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)