LigaSure Blunt Tip Laparoscopic Sealer Devices Recalled for Jaw Opening Defect
Covidien is recalling LigaSure Blunt Tip Laparoscopic Sealer/Divider devices (lot 11320187X) due to an assembly defect that may prevent the device jaws from opening after tissue application, creating a risk of bleeding and tissue injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a potential assembly defect that could cause bleeding and unintended tissue injury. No illnesses or injuries have been reported. This meets the rubric criteria for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Covidien LLC is recalling the LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated (Product Number LF1837, Lot Number 11320187X). The device is a surgical instrument used in laparoscopic procedures.
The recall is prompted by a potential assembly issue that can cause the device jaws to become difficult to open or fail to open after application on tissue. This malfunction could result in bleeding, unintended tissue injury or loss, and delays in surgical treatment while an alternate device is obtained.
The affected devices were distributed worldwide to Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, and United Kingdom. No devices were distributed in the United States.
The recalled product
- Product
- LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
- Manufacturer
- Covidien Llc
- Affected units
- 504
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 20884521705880 10884521705883
- Lot Number: 11320187X
Distribution
Distribution scope not specified by the agency.
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