Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk
Medtronic is recalling 19,200 Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
What this means for you
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 involves a medical device with a potential sterile barrier breach, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic is recalling 19,200 units of Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes (3-inch, Item Code E25303). 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 recall is being conducted because there is a potential for compromise of the package, which could result in a breach of the sterile barrier. The affected lot range is 210286X through 61220102X.
The products were distributed worldwide, including nationwide in the United States and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand. Healthcare facilities should stop using these devices and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 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
- Manufacturer
- Medtronic
- Affected units
- 19,200
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: 210286X through 61220102X
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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