Halo D7T20P15RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835000351), received between Nov 28, 2018 and May 31, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionMay 31, 2024Contamination /Decontamination Problem; Positioning Problem; Contamination /Decontamination Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A HALO¿ XP ELECTROPHYSIOLOGY CATHETER AND THERE WAS SOME GLUE AROUND THE PLUNGER PART OF THE CATHETER HANDLE. IT WAS REPORTED BY THE CALLER AT THE END OF THE PROCEDURE WHEN THE PHYSICIAN REMOVED THE CATHETER FROM THE BODY IT WAS OBSERVED THAT THERE WAS SOME GLUE AROUND THE PLUNGER. CALLER ALSO STATED THAT THE CATHETER WAS NOT MOVING AND DEFLECTING AS IT SHOULD. THERE WAS NO RESISTANCE. THE PHYSICIAN HAD DIFFICULTY MANEUVERING THE CATHETER AND KEEPING IT IN PLACE THROUGH THE CASE. THE PATIENT DID HAVE A SMALLER HEART IN COMPARISON TO OTHER PATIENTS NORMALLY SEEN. IT WAS NOT BELIEVED THE CATHETER¿S PEBAX WAS DAMAGED. THE GLUE WAS ONLY ON THE PLUNGER PART OF THE CATHETER HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19436426 ↗
• InjuryNov 28, 2018Entrapment of Device; Failure to Unfold or Unwrap; Entrapment of Device; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE ON WHICH THE HALO¿ XP ELECTROPHYSIOLOGY CATHETER BECAME ENTRAPPED IN THE RIGHT ATRIUM REQUIRING SURGICAL INTERVENTION TO REMOVE IT. DURING THE PROCEDURE, THE HALO¿ XP ELECTROPHYSIOLOGY CATHETER WAS USED FOR A ST. JUDE /ABBOT ESI MAPPING AND BECAME KNOTTED AND GOT ENTANGLED IN THE RIGHT ATRIUM (RA). THE CATHETER COULD NOT BE REMOVED SAFETY FROM THE PATIENT¿S BODY VIA THE SHEATH. A SURGICAL VEIN CUTDOWN INTERVENTION WAS PERFORMED TO REMOVE THE CATHETER FROM THE PATIENT¿S BODY. THE PATIENT COMPLAINED ABOUT SORENESS IN GROIN; THEREFORE, IT STAYED AN OVERNIGHT FOR GROIN MONITORING AND WILL REQUIRE A FOLLOW UP 4 WEEKS AFTER THE PROCEDURE WITH VASCULAR AND 2-3 MONTHS FOLLOW UP WITH THE PHYSICIAN FOR POSSIBLE RE-EVALUATION OF ABLATION TREATMENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT OCCURRED DUE TO CHALLENGES DURING CATHETER PLACEMENT WHICH CAUSED THE CATHETER KNOTTED IN THE SHEATH. THERE WAS NO PHYSICAL DAMAGE SUCH AS EXPOSURE OF ANY INTERNAL CATHETER COMPONENT, ELECTRODE SHARP EDGES OR COMPONENT DETACHMENT. THE SHEATH USED DURING THE PROCEDURE WAS A ST

  Patient problems: No Code Available

  MAUDE report 8113694 ↗