Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk
Medtronic is recalling Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
What this means for you
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. The hazard is a potential sterile barrier breach, which is a significant risk but does not meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I).
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes (Item Code: E253028) due to a potential compromise of the package that could result in a breach of the sterile barrier. The affected units are distributed worldwide, including in the United States, Australia, Canada, Japan, Korea, Hong Kong, and Thailand.
The recall covers 13,420 units with lot numbers ranging from 210141X through 61220104X. These electrodes 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.
Healthcare providers and facilities should stop using the affected devices and contact Medtronic for further instructions regarding the recall.
The recalled product
- Product
- Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 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 v
- Manufacturer
- Medtronic
- Hazard
- Affected units
- 13,420
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: 210141X through 61220104X
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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