Medtronic Valleylab Laparoscopic Electrode Recalled for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Flat L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 119,770 units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the potential for sterile barrier breach in a surgical device represents a significant risk of infection, aligning with the Severe category for high-risk medical device defects.
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Flat L-Hook Electrodes (Item Code: E277436) because of a potential compromise of the package that could result in a breach of the sterile barrier. The product is 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 affects 119,770 units with lot numbers ranging from 210652X through 61390114X. These products were distributed nationwide in the United States and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand.
This is an FDA Class II recall. Healthcare facilities should stop using the affected devices and contact Medtronic for further instructions.
The recalled product
- Product
- Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 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 single
- Manufacturer
- Medtronic
- Affected units
- 119,770
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: 210652X through 61390114X
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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