Agilis HisPro™ DS3H010-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067032287), received between May 19, 2022 and Jan 9, 2023 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation 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 18, 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.

• InjuryJan 9, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  RELATED MANUFACTURING REFERENCE NUMBER: 2017865-2023-00728. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD PERFORATED THE LEFT VENTRICLE. THE PHYSICIAN ALLEGED THAT THE PERFORATION WAS CAUSED BY THE HIGH PULL BACK STRENGTH OF THE CATHETER. THE LEAD WAS REPOSITIONED SUCCESSFULLY. NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Cardiac Perforation

  MAUDE report 16127189 ↗
• DeathMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-10397, 2017865-2022-10398. DURING A DEVICE UPGRADE PROCEDURE, THE TENDRIL LEAD WAS ATTEMPTED TO BE IMPLANTED USING THE HISPRO CATHETER. AN ACCEPTABLE IMPLANT POSITION COULD NOT BE FOUND, SO A NEW APPROACH WAS ATTEMPTED WITH A CPS DIRECT UNIVERSAL CATHETER. LEAD PLACEMENT WAS AGAIN UNSUCCESSFUL, SO THE HISPRO CATHETER WAS AGAIN ATTEMPTED. AT THIS TIME, A DROP IN BLOOD PRESSURE OCCURRED WHICH WAS SUCCESSFULLY RESOLVED WITH MEDICATION. LEAD PLACEMENT WAS AGAIN ATTEMPTED BEFORE THE PHYSICIAN ELECTED TO ABORT THE IMPLANT PROCEDURE AND REMOVE THE HISPRO CATHETER. THE PATIENT'S BLOOD PRESSURE AGAIN DROPPED, HOWEVER, MEDICATION WAS UNSUCCESSFUL. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND MAINTAINED FOR 15 MINUTES. CHEST DRAINAGE WAS PERFORMED WHICH REVEALED BLEEDING AND A HEMOTHORAX. CPR WAS STOPPED AND THE PATIENT WAS PRONOUNCED DECEASED. THE PHYSICIAN SUSPECTED A PERFORATION OF THE SUPERIOR VENA CAVA OCCURRED EARLY IN THE PROCEDURE WHEN ACCESSING THE SUBCLAVIAN VEIN SYSTEM. THE PHYSICIAN DID NOT ALLEGE A MALFUNCTION ON ANY ABBOTT PRODUCT, NOR DID THEY ALLEGE ANY ABBOTT PRODUCT DIRECTLY CAUSED OR CONTRIBUTED TO THE PATIENT'S PASS

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 14434637 ↗