SOFTRACE 2331C-003Recalls & reported problems
Conmed Corporation · SOFTRACE MEDIUM RTL, NEONATAL/PEDIATRIC ECG ELECTRODE · Class 2
Data updated Oct 13, 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 30653405064132), received between Aug 26, 2021 and Aug 26, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Human-Device Interface Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Human-Device Interface Problem1
- Separation Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2021Human-Device Interface Problem; Separation Problem; Human-Device Interface Problem; Separation Problem
ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED ISSUES WITH THE ECG PEDIATRIC ELECTRODE (SOFTRACE MEDIUM RTL) ITEM # 2331C-003, LOT 202106105, THAT WAS EXPERIENCED ON (B)(6) 2021. INFORMATION RECEIVED INDICATES ONLY THAT THE PATIENT SWALLOWED ELECTRODE AFTER BREAKING IT APART¿ IT IS NOTED A SURGICAL PROCEDURE WAS NEED TO RETRIEVE ELECTRODE FROM PATIENT. THE PATIENT STATUS IS LISTED TO BE ¿STABLE¿. ADDITIONAL INFORMATION PROVIDED INDICATES THE PATIENT INVOLVED WAS UNDER 1 YEAR OF AGE. THE ISSUE OCCURRED WHILE PATIENT WAS IN THE NICU AND THE DEVICE WAS BEING USED FOR GENERAL MONITORING. IT IS UNKNOWN WHERE ON THE PATIENTS BODY THE DEVICE WAS LOCATED OR HOW LONG THE DEVICE HAD BEEN IN PLACE WHEN THE ISSUE OCCURRED. IT IS UNKNOWN WHERE THE PIECES OF THE DEVICE WERE FOUND IN THE PATIENT DURING THE SURGERY, ONLY THAT ALL PIECES WERE REMOVED. NO OTHER CLARIFICATION WAS PROVIDED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS A SURGICAL PROCEDURE WAS NEEDED TO REMOVE THE PIECES AFTER INGESTION.
Patient problems: Insufficient Information
MAUDE report 12372102 ↗
Other Electrode, electrocardiograph devices
- Vermed A10091-30Graphic Controls Acquisition Corp · Electrode, Electrocardiograph132 reports
- 3M™ 22283m Company · Electrode, electrocardiograph2 recalls0 reports
- 3M™ Red Dot™ 22283m Company · Electrode, electrocardiograph1 recall4 reports
- Vital Signs™ 2464AAO-20AirLife Finland Oy · Electrode, electrocardiograph51 reports
- Vermed IP-Set M5 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set 12 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set N3-Pediatric-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
- Vermed IP-Set M3 RT Adult-USGraphic Controls Acquisition Corp · Electrode, Electrocardiograph1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page