FDA-Device2022-01-19Class II

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

Covidien Llc
Hazard

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.

Sold states
Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.
Affected count
504 devices
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0495-2022

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