Z-0495-2022Class II

LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837

Name: Z-0495-2022 LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Creator: Covidien Llc
Published: 2021-12-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-12-06 / Terminated / root cause: design

FDA source

Covidien Llc began a recall of LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 on 2021-12-06. FDA classified it as Class II and gives the reason as "Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended...". 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-0495-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-06
Posted: 2022-01-13
Terminated: 2023-05-11
Recalling firm: Medtronic, Inc.
Product: LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.
Root cause tag: design
FDA root cause: Device Design
Action: URGENT MEDICAL DEVICE RECALL notification letters dated 12/2021 were sent to customers. Customer Action Required: 1. Please immediately quarantine and discontinue use of the affected item code with the associated lot number listed above. 2. Please return affected product as indicated below. All products from the affected item code and associated lot number must be returned. 3. If you have distributed the product item code and lot number listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory and email it to [email protected] We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please do not hesitate to contact Azi Hosseini on +61 428 464 838, or [email protected]
Quantity in commerce: 504 devices
Distribution: Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.
Product codes and lots: UDI: 20884521705880 10884521705883; Lot Number: 11320187X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0495-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0495-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-19	2022-01-13

Product code GEI

K162941Class IILigasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien / cleared 2016-11-14

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)