Radia™ M004320020G0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729877950), received between Jun 10, 2020 and Jul 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2022. DURING PREPARATION, A RADIA CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT THE CATHETER WAS DEFECTIVE AND DID NOT WORK. A DIFFERENT CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. DURING PRODUCT ANALYSIS, IT WAS OBSERVED THE DISTAL END DETACHED FROM THE CATHETER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15016067 ↗
• MalfunctionJun 10, 2020Material Perforation; Material Deformation; Material Perforation; Material Deformation

  IT WAS REPORTED THERE WAS A SEPARATION IN THE INSULATION OF THE CATHETER. DURING AN ABLATION PROCEDURE FOR PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) WITH A RADIA CATHETER, THE CATHETER HAD A FRACTURE AND SEPARATION OF INSULATION MATERIAL ON THE CURVE. THE PHYSICIAN COMPLETED THE PROCEDURE USING ANOTHER CATHETER. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138565 ↗