Medtronic Aquamantys3 Pump Generator Recalled for Electrical Safety Defect
Medtronic is recalling 242 Aquamantys3 Pump Generators because internal protection circuitry may fail, exposing patients to DC voltage during surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, and the hazard involves potential electrical shock (DC voltage exposure) to patients during surgery, which constitutes a significant injury risk.
Plain-English summary
Medtronic Advanced Energy, LLC is recalling 242 units of the Aquamantys3 Pump Generator (Catalog Numbers 10-1357 and 40-404-1). The device is a medical instrument that combines radio frequency energy and saline to reduce blood loss during surgical procedures.
The recall is due to a defect in the internal protection circuitry on the electrosurgical output. This circuitry is designed to prevent patients from exposure to DC voltage when the device is activated. The company reports that this protection is being compromised during normal use.
The affected devices were distributed nationwide, including in California, Missouri, Pennsylvania, New Jersey, New York, Ohio, Virginia, Texas, North Carolina, Delaware, Kansas, Tennessee, Louisiana, Illinois, Michigan, South Carolina, Wisconsin, and Florida. The serial numbers for the recalled units range from GN001141 to GN001704 (non-consecutive). Healthcare facilities should contact Medtronic Advanced Energy for instructions on how to return or replace the devices.
The recalled product
- Product
- Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical…
- Manufacturer
- Medtronic Advanced Energy, LLC
- Affected units
- 242
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 (2)
- lowest serial number is GN001141
- the highest is GN001704 (non-consecutive)
Distribution
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