Edison EDNTC1001 (UDI 00850006962327)Recalls & reported problems

Histosonics, Inc. · Treatment Cart · Class 2

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 00850006962327), received between Sep 24, 2026 and Sep 24, 2026 — 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. How this data works · Data updated Oct 13, 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

Hematuria1
Hyponatremia1
Urinary Retention1

Recent adverse event reports

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

InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
As part of the BOOMBOX post-market clinical study, on (b)(6) 2026, a 72-year-old male patient with a history of hepatocellular carcinoma received a histotripsy treatment to a single tumor in liver segment VI for a total planned treatment volume (PTV) of approximately 18.76 cc. Post-operative day (POD) 3, the patient presented to the emergency department with urinary retention and hematuria. A Foley catheter was placed, and laboratory testing revealed a sodium level of 119 mEq/L, requiring hospitalization for correction of hyponatremia, reportedly likely secondary to urinary retention. Bladder irrigation was performed to clear the blood clots. Hematuria, urinary retention, and hyponatremia were reported as resolved on POD5, the Foley catheter was removed and the patient was discharged that day.
Patient problems: Hematuria; Hyponatremia; Urinary Retention
MAUDE report 50887178 ↗

Device details

UDI-DI	`00850006962327`
Brand	Edison
Model	EDNTC1001
Company	Histosonics, Inc.
Product code	QGM · Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 12, 2026

Device type (GMDN): Therapeutic oncological/gynaecological ultrasound system

An assembly of electrically-powered devices designed to treat solid tumours of hard (bone) and/or soft tissue [e.g., liver, kidney, breast, prostate] and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through noninvasive or non-surgically invasive localized application of high intensity focused ultrasound (HIFU) or high intensity therapeutic ultrasound (HITU) intended to gradually denature/ablate tissue lesions. It typically consists of a piezoelectric transducer (probe), a water supply/power control unit, operator console and monitoring systems, software, and sometimes a patient table. Optimal patient positioning is achieved using an ultrasound scanner or MRI system.

Other Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation devices

Edison EDNTC1001
Histosonics, Inc. · Ultrasound Histotripsy System
4 deaths43 reports
Edison EDNTC1001
Histosonics, Inc. · Ultrasound Histotripsy System
6 deaths29 reports

All Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.