Rhythmia HDx™ Mapping System M004RAPATCH20Recalls & reported problems
Boston Scientific Corporation · Location Reference Patch Kit · Class 2
Data updated Oct 13, 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 00191506000813), received between Jul 16, 2024 and Jul 16, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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.
Reports received per month
Most reported problems
Device problems
- Contamination1
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.
MalfunctionJul 16, 2024Contamination; Contamination
IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION (AFIB), A LOCATION REFERENCE PATCH KIT WAS SELECTED FOR USE. ONE OF THE PATCHES WAS DIRTY, AND THERE SEEMED TO BE FOREIGN OBJECT. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY USING ANOTHER PATCH FROM THE SAME PACKAGE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19754985 ↗
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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.
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