Entrant™ CDHFA300DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067050120), received between Jan 7, 2026 and May 18, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Over-Sensing

  IT WAS REPORTED THAT PATIENT PRESENTED FOR IN CLINIC FOLLOW-UP. DEVICE INTERROGATION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INTERMITTENT CROSSTALK RESULTING IN PACING INHIBITION. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204448 ↗
• MalfunctionApr 14, 2026Over-Sensing

  IT WAS REPORTED POST IMPLANT PROCEDURE, EPISODES OF CROSSTALK OVERSENSING WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVE THE EVENT. REPROGRAMMING HAS BEEN PERFORMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877770 ↗
• MalfunctionApr 8, 2026Over-Sensing

  DURING A REMOTE FOLLOW-UP, EPISODES OF POST-PACED T-WAVE OVERSENSING (PPTWOS) WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVE THE EVENT. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816067 ↗
• MalfunctionMar 2, 2026Loose or Intermittent Connection

  DURING THE INITIAL IMPLANT PROCEDURE, WHILE ATTEMPTING TO TIGHTEN THE SET SCREW TO SECURE THE LEAD, THE SET SCREW WAS STRIPPED AND WAS NO LONGER ABLE TO ROTATE. A NEW DEVICE WAS SELECTED AND SUCCESSFULLY IMPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480220 ↗
• MalfunctionFeb 24, 2026Loose or Intermittent Connection

  DURING THE INITIAL IMPLANT PROCEDURE, THE SET SCREW WAS UNABLE TO BE TIGHTENED ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24438710 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH WOUND DEHISCENCE AND A SUSPECTED INFECTION. THE DEVICE AND LEADS WERE ERODED. TO RESOLVE THE ISSUE, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2026 TO REMOVE THE ENTIRE SYSTEM, INCLUDING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE RIGHT ATRIAL (RA) LEAD, AND THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 24381934 ↗
• MalfunctionFeb 9, 2026Failure to Capture

  IT WAS REPORTED THAT A LOSS OF CAPTURE WAS OBSERVED ON THE DEVICE. IT IS UNKNOWN IF THE PATIENT IS PACEMAKER DEPENDENT. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24297606 ↗
• MalfunctionJan 7, 2026High impedance

  DURING THE INITIAL IMPLANT PROCEDURE, THE PACING IMPEDANCE INCREASED WHEN THE LEAD WAS CONNECTED TO THE HEADER OF THE DEVICE. A NEW DEVICE WAS SELECTED AND CONNECTED TO THE LEAD TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987114 ↗