HELIOS HK05110URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836559007265), received between Jul 18, 2017 and Jul 18, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K861403); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2017Break; Material Integrity Problem; Break; Material Integrity Problem

  THE CUSTOMER REPORTED THEY RECEIVED A COMPLAINT FROM (B)(6). THE PATIENT HAS BEEN HARMED. ACCORDING TO THE HOSPITAL, IT WAS NOTICED THAT THE PART OF THE SLUICE THAT IS INTRODUCED OF ADELANTE SIGMA PLUS OF THE HELIOS CONVENIENCE KIT IS TORN OFF IN THE PATIENT. THE FRAGMENT CAME WITH THE BLOOD FLOW INTO THE HEART AND COULD BE RECOVERED BY EMERGENCY SURGERY. ACCORDING TO OUR MR. (B)(6), THE PATIENT WAS IN DANGER OF LIFE. ADDITIONAL INFORMATION AND THE RETURN OF THE PRODUCT - IF POSSIBLE - WILL FOLLOW. ON 6/21/2017 ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: PLEASE LET ME DESCRIBE ME IN DETAIL THE COMPLAINT OF THE HOSPITAL IN (B)(6). THE HELIOS CONVENIENCE KIT HAS BEEN USED IN THE INTENSIVE CARE UNIT FOR CRITICAL SITUATIONS ONLY. SO FAR THEY USED AROUND FIVE HELIOS CONVENIENCE KITS. DURING EXTRACTING THE HELIOS AND ADELANTE SIGMA PLUS THE DOCTOR RECOGNIZED, THAT HE DIDN'T SEE THE WHITE SHEATH OF THE SIGMA PLUS BUT ONLY THE BLUE PART OF THE HELIOS SHEATH. THE PATIENT GOT IMMEDIATELY AN EMERGENCY ANGIOGRAPHY. DURING THIS PROCEDURE THE SHEATH OF THE SIGMA PLUS HAS BEEN DETECTED IN THE RIGHT VENTRICLE. THEY COULD SAVE THE SHEATH WITH A SNARE. THE PART OF THE SIGMA PLUS HAS BEEN EXTRACTE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6723328 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K861403. One submission often covers many models, so check the product and lot details in each record.

• Z-0391-2019 · Sep 26, 2018 · Terminated
  TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray