Autolith Touch M0054668R0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817183020523), received between Nov 10, 2023 and Nov 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K130368); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionNov 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 09/21/2023 NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ALLEGED MALFUNCTION OF THE DEVICE THAT PREVENT THE DEVICES FROM BEING USED (BLANK SCREEN). THE DEVICE WAS NOT RETURNED FOR EVALUATION UNTIL 09/28/2023. DURING THE SERVICE EVALUATION IT WAS IDENTIFIED THAT THE INSULATED WIRES FROM THE HIGH VOLTAGE TRANSFORMER WERE DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE DEVICE AMONG A NUMBER OF OTHER INSTANCES OF PHYSICAL DAMAGE NOTED TO THE EXTERIOR AND INTERIOR OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112272 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130368. One submission often covers many models, so check the product and lot details in each record.

• Z-1235-2022 · Apr 13, 2022 · Terminated
  AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
• Z-0333-2022 · Oct 25, 2021 · Open, Classified
  Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL p
• Z-1884-2020 · Mar 10, 2020 · Terminated
  AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
• Z-1883-2020 · Mar 10, 2020 · Terminated
  Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.