RHYTHMIA HDx™ M004RA71010Recalls & reported problems
Boston Scientific Corporation · Localization Generator Cable · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729938545), received between May 7, 2026 and May 7, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Communication or Transmission Problem2
- Device Sensing Problem2
- Loose or Intermittent Connection2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Loose or Intermittent Connection; Communication or Transmission Problem; Device Sensing Problem
IT WAS REPORTED THAT THE MAGNETIC LOCATION WAS LOST AND CATHETER COULD NOT BE VISUALIZED WHILE USING A LOCALIZATION GENERATOR CABLE, ADDITIONALLY ERROR 1105-2 AND 1113-2 WERE DISPLAYED. PICTURE PROVIDED SHOWED ERROR CODE 1318. NO PATIENT COMPLICATIONS OCCURRED. CASES WERE POSTPONED UNTIL REPLACEMENT. THERE IS NOT ANY INDICATION IF THE DEVICE WILL BE RETURNED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25118013 ↗MalfunctionMay 7, 2026Loose or Intermittent Connection; Communication or Transmission Problem; Device Sensing Problem
IT WAS REPORTED THAT THE MAGNETIC LOCATION WAS LOST AND CATHETER COULD NOT BE VISUALIZED WHILE USING A LOCALIZATION GENERATOR CABLE, ADDITIONALLY ERROR 1105-2 AND 1113-2 WERE DISPLAYED. PICTURE PROVIDED SHOWED ERROR CODE 1318. NO PATIENT COMPLICATIONS OCCURRED. CASES WERE POSTPONED UNTIL REPLACEMENT. THERE IS NOT ANY INDICATION IF THE DEVICE WILL BE RETURNED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117981 ↗
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- MR Patient Care Short Wide ECG 2.0 Cable AAMI CAB,4 LD,CV MRI ECGPhilips Ds North America LLC · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)12 reports
- NA 5492ALMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)10 reports
- NA 5492VLMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)10 reports
- NA 5487LMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)8 reports
- CORE M2 Vascular System 400-0100.17Volcano Corporation · Cable, Transducer And Electrode, Patient, (Including Connector)6 reports
- NA 5487Medtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.