Valleylab Laparoscopic Handset Recalled for Activation Button Failure
COVIDIEN MEDTRONIC is recalling Valleylab Laparoscopic Handsets because customer reports indicate the device may continue operating after the activation button is released.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (electrical surgical device) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
COVIDIEN MEDTRONIC is recalling Valleylab Laparoscopic Handsets, including Material # E2750 and Material # E2750NSB. The recall involves 24,703 units that were distributed worldwide and nationwide in the United States across 31 states.
The recall was initiated due to customer reports that the device handset continues to operate after the activation button is released. This failure mode presents a risk of unintended electrical energy delivery during laparoscopic and thorascopic procedures.
Healthcare facilities and consumers who have these devices should stop using them immediately. They should contact COVIDIEN MEDTRONIC for instructions on how to return the devices for repair or replacement.
The recalled product
- Product
- Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of…
- Manufacturer
- COVIDIEN MEDTRONIC
- Affected units
- 24,703
Distribution
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