Medtronic Recalls Laparoscopic Argon Sharp Needle Electrodes Due to Sterile Barrier Risk
Medtronic is recalling 210 units of Valleylab Laparoscopic Argon Sharp Needle Electrodes due to a potential sterile barrier breach.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential sterile barrier breach without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic is recalling 210 units of the Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM (Item Code: E258228). The recall is due to a potential compromise of the package that could result in a breach of the sterile barrier. The affected lot range is 216416X through 60080002X.
These devices are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation, and suction via a single handset is desirable. The products were distributed worldwide, including nationwide in the US and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand.
Healthcare providers should stop using the affected devices and contact Medtronic for further instructions. Patients who have had procedures using these devices should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 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
- Hazard
- Affected units
- 210
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: 216416X through 60080002X
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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