NA BIOCR3434CTRecalls & reported problems
Sterilmed, Inc. · CABLE INTERFACE CARTO 3 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551006200), received between May 15, 2024 and May 15, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Signal Artifact/Noise” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Signal Artifact/Noise1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2024Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED CABLE INTERFACE CARTO 3 AND WHEN PLUGGED IN, THE ELECTROCARDIOGRAM (ECG) SIGNALS DISAPPEARED. THERE WAS NO ECG SIGNAL, IT WAS VERY NOISY AND THERE WAS A LOT OF NOISE ON THE CATHETER SIGNAL. THE SIGNAL ISSUE WAS OBSERVED ON THE BODY SURFACE SIGNAL, THE CARTO 3 SYSTEM® AND RECORDING SYSTEM. THE PHYSICIAN DID NOT HAVE AT LEAST ONE ECG SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. THE ISSUE WAS RESOLVED BY USING A NEW CABLE. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19327018 ↗
Other CATHETER, RECORDING, ELECTRODE, REPROCESSED devices
- MEDLINE 401904RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed3 recalls1 report
- MEDLINE 401582RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed3 recalls0 reports
- MEDLINE 401474RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls1 report
- MEDLINE 401309RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE 401435RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE 81104RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE 401652RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 reports
- MEDLINE 401891RHMedline Industries, Inc. · Catheter, recording, electrode, reprocessed2 recalls0 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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