HELIOS H05110URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836559006640), received between Oct 8, 2018 and Dec 31, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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.

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.

• MalfunctionDec 31, 2018Material Rupture; Material Rupture

  ON (B)(6) 2019, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED, ATTEMPTED TO CONNECT THE HELIOS WITH A TEMPORARY PACEMAKER ON ICU. A 6 FRENCH SHEATH WAS USED; CATHETER COULD NOT BE PUSHED THROUGH THE SHEATH AND TORE WHILE TRYING. FINALLY ANOTHER CATHETER WAS USED, NO FURTHER PROBLEMS. THERE WERE NO IDENTIFIABLE PROBLEMS WITH THE PATIENT. IT WAS NOT DOCUMENTED IF THE BALLOON WAS TESTED PRIOR TO USE, NOR HOW MUCH AIR WAS INSERTED INTO THE BALLOON. THE ISSUE WAS RESOLVED BY USING ANOTHER CATHETER. IT CANNOT BE CONFIRMED IF THE PRODUCT WAS INSIDE OR OUTSIDE OF THE PATIENT WHEN THE EVENT OCCURRED. THE CLINIC WAS CALLED BUT WAS INFORMED THEY DID NOT DOCUMENT THE COMPLAINT AS SUCH.

  Patient problems: No Information

  MAUDE report 8206739 ↗
• MalfunctionOct 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING IMPLANTING THE ELECTRODE FOR TEMPORARY STIMULATION OF THE HEART, THE HELIOS BALLOON WAS INFLATED TO 3MM AND BURST. THE SYRINGE USED WAS THE ONE SUPPLIED IN THE KIT TOGETHER WITH THE HELIOS. THE ISSUE WAS RESOLVED BY OPENING ANOTHER HELIOS UNIT AND INFLATING TO 1MM. NO ADDITIONAL INFORMATION IS AVAILABLE AND NO OTHER ADVERSE EVENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7944802 ↗