External Remote Controller ERC 3PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517001344), received between Jan 21, 2020 and Jul 31, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2020Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT THE UNIT STOPPED LENGTHENING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 10348662 ↗
• MalfunctionJan 21, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT THE ELECTRONIC REMOTE CONTROLLER (ERC) WAS LENGTHENING AT DOUBLE THE SPEED IT WAS ORIGINALLY PROGRAMMED FOR. PATIENT EXPERIENCED PAIN BUT NO HARM WAS REPORTED.

  Patient problems: Pain

  MAUDE report 9612727 ↗