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Recall Observatory FDA recall evidence

Device product

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

Z-0495-2022

December 06, 2021

Class II

Product summary

Firm
Covidien Llc
Event
Event 89182
Status
Terminated
Classification
Class II
Quantity
504 devices
Official record key
device-enforcement:Z-0495-2022

Official wording

Reason: 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.

Code information: UDI: 20884521705880 10884521705883; Lot Number: 11320187X

Distribution pattern: Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    assembly issue