Medtronic Valleylab Laparoscopic Electrodes Recalled for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall affects 6,381 units distributed worldwide.
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. The hazard is a potential sterile barrier breach, which poses a risk of infection (risk-of-harm product) but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes (Item Code: E277145) because of a potential for compromise of the package resulting in a breach of the sterile barrier. The affected lot range is 209505X through 61220130X.
The recall involves 6,381 units that were distributed nationwide in the US and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand. These devices are indicated for use in laparoscopic and thoracoscopic surgical procedures.
Healthcare providers should stop using the affected devices and contact Medtronic for further instructions. Patients who have had surgery with these devices should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
- Manufacturer
- Medtronic
- Affected units
- 6,381
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 (1)
- Affected Lot Range: 209505X through 61220130X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Medtronic under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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