The Recall Desk
HighFDA (Devices)·Z-0258-2022·Announced 2021-11-24

LEEP PRECISION Integrated System may fail to coagulate during surgery

CooperSurgical is recalling 75 units of the LEEP PRECISION Integrated System due to a defect where the hand switch may not activate the coagulation function, potentially causing prolonged surgery and bleeding complications.

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: This is an FDA Class II medical device recall affecting surgical equipment where the coagulation function may fail during procedures. While no illnesses or injuries have been reported, the potential for intraoperative bleeding complications requiring medical intervention represents a risk-of-harm scenario where injury has not yet been reported, justifying a High severity rating.

Plain-English summary

CooperSurgical, Inc. is recalling 75 units of the LEEP PRECISION Integrated System, 220V (part number LP-10-220). The recall covers devices with specific serial numbers manufactured between 2017 and 2021.

The device's coagulation function may not operate when the hand switch is used. If the device fails to coagulate tissue during a procedure, it may result in prolonged surgery and intraoperative bleeding, which would require medical intervention to control.

The affected devices were distributed nationwide throughout the United States and to 38 countries worldwide, including Canada, Mexico, the United Kingdom, Germany, China, India, and others.

The recalled product

Product
LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
Manufacturer
CooperSurgical, Inc.
Category
Medical Device — Surgical Coagulation Equipment
Hazard
  • device-malfunction
  • coagulation-failure
  • intraoperative-bleeding

Distribution

Distributed nationwide across the United States.

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