ECG Cables and Leadsets CBL 3 Lead ECG Trunk, AAMI/IEC 2.7mRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884838011632), received between Jun 3, 2019 and May 29, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2020Break

  THE CUSTOMER REPORTED THE DAMAGE OF THE ECG CABLE DUE TO DECONTAMINATION PRODUCT. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10100850 ↗
• MalfunctionFeb 19, 2020Defective Component

  THE CUSTOMER REPORTED A FAILURE OF THE ECG TRUNK CABLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9727411 ↗
• MalfunctionFeb 16, 2020Computer Operating System Problem

  THE CUSTOMER REPORTED A FAILURE OF THE ECG TRUNK CABLE. THERE WAS NO REPORTED PATIENT INCIDENT/INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9715300 ↗
• MalfunctionJan 28, 2020Defective Component

  THE CUSTOMER REPORTED A FAILURE OF THE ECG TRUNK CABLE. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORTED PATIENT INCIDENT/INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9636551 ↗
• MalfunctionJul 22, 2019Material Erosion

  THE CUSTOMER REPORTED THE TRUNK CABLES ARE ERODED.. THERE WAS NO REPORTED PATIENT INCIDENT/INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8813124 ↗
• MalfunctionJun 3, 2019Melted

  THE CUSTOMER STATED THAT THE PLASTIC ON THE CABLE COMPLETELY MELTED REVEALING THE METAL PART THERE WAS NO REPORTED PATIENT INCIDENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8662829 ↗