LEEP PRECISION Electrosurgical System Coagulation Function May Fail
CooperSurgical's LEEP PRECISION System may fail to coagulate tissue when using the hand switch, potentially requiring medical intervention to control intraoperative bleeding during procedures.
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: This is an FDA Class II surgical device with a functional defect that could lead to intraoperative complications requiring medical intervention, but no reported injuries or incidents are documented in the source, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
CooperSurgical's LEEP PRECISION Integrated System, model LP-10-120 (120V), is being recalled due to a defect affecting the coagulation function.
The coagulate function may not operate properly when using the hand switch. Failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control intraoperative bleeding and complete the surgical case.
The recall affects 1,587 units distributed in the US and internationally across 35+ countries. Affected facilities should contact CooperSurgical for information regarding affected serial numbers and appropriate corrective actions.
The recalled product
- Product
- LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 1,587
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by CooperSurgical, Inc. 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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