LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling 504 units of the LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated (Product Number LF1837, Lot Number 11320187X) due to an assembly issue that causes the device jaws to become difficult to open or fail to open after being applied to tissue. This malfunction could lead to bleeding, unintended tissue damage or loss, and treatment delays while obtaining an alternative device. The affected devices were distributed worldwide in Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, and the United Kingdom, with no distribution in the United States.
The recall notice does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution. Quantity: 504 devices Lot/code info: UDI: 20884521705880 10884521705883; Lot Number: 11320187X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.