Acessa ProVu System 3000Recalls & reported problems

Hologic, Inc. · The Acessa ProVu Grounding Pads · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045515253), received between Feb 5, 2025 and Feb 5, 2025 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Localized Skin Lesion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2024, THE PHYSICIAN REPORTED THAT DURING A FOLLOW UP, THE PATIENT HAD WHAT LOOKED LIKE SMALL BURNS ON HER LEGS OR INNER THIGH AND THE PHYSICIAN BELIEVED TO BE FROM THE GROUNDING PADS. IMAGES PROVIDED COULD NOT CONFIRM THE ORIGIN OF THE SKIN LESIONS. PHYSICIAN REPORTED THAT THE PATIENT WAS HEALING FINE AND NO ADDITIONAL CARE WAS REQUESTED. NO OTHER INFORMATION AVAILABLE.
Patient problems: Localized Skin Lesion
MAUDE report 21315708 ↗

Device details

UDI-DI	`15420045515253`
Brand	Acessa ProVu System
Model	3000
Company	Hologic, Inc.
Product code	HFG · COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 16, 2024

Device type (GMDN): Electrosurgical return electrode, single-use

A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.

Other COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) devices

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CONMED 60-5163-001
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Acessa ProVu System 7100
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3 reports
Acessa ProVu System 7700
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3 reports
Acessa ProVu System 5200
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1 report

All COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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