NA 405108Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05415067040879), received between Jun 24, 2022 and Apr 1, 2025 — classified as 2 deaths, 4 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. THE DAY AFTER THE PROCEDURE, THE PATIENT PASSED AWAY. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21748600 ↗
• DeathApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. THE DAY AFTER THE PROCEDURE, THE PATIENT PASSED AWAY. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21748599 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, A PNEUMOTHORAX OCCURRED WHICH REQUIRED RESUSCITATION. DURING IMPLANTATION, THE PATIENT¿S VITAL SIGNS AND OXYGEN SATURATION BECAME POOR. THE ANESTHESIOLOGIST ASKED THAT THE OPERATION BE INTERRUPTED TO STABILIZE THE PATIENT. WHEN THE CS WAS VISUALIZED, USING THE BALLOON CATHETER, CONTRAST MEDIUM ENTERED THE ENTIRE HEART. AN ULTRASOUND WAS USED TO SEE WHERE THE PROBLEM WAS. THE PATIENTS BLOOD PRESSURE DROPPED AND A PNEUMOTHORAX WAS NOTED. AN ATTEMPT WAS MADE TO CORRECT THE PNEUMOTHORAX WITH HELP OF A DRAINAGE. THE PATIENT REQUIRED RESUSCITATION, THE PHYSICIANS BEGAN CHEST COMPRESSIONS, AND THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT UNDER THE ACCOMPANIMENT OF THE INTERNAL RESCUE TEAM AND THE PROCEDURE WAS ABORTED. IT WAS NOTED THAT THE PNEUMOTHORAX LIKELY OCCURRED DURING PUNCTURE OF THE SUBCLAVIAN VEIN.

  Patient problems: Pneumothorax

  MAUDE report 18807372 ↗
• InjuryAug 27, 2023Difficult to Insert; Difficult to Insert

  DURING A PACEMAKER IMPLANTATION PROCEDURE, IT WAS NOTED THAT THE GUIDE WIRE DID NOT PROGRESS INSIDE THE INTRODUCER LUMEN. THE INTRODUCER WAS EXCHANGED AND A NEW PUNCTURE IN THE SUBCLAVIAN VEIN WAS NECESSARY. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17629119 ↗
• InjuryDec 4, 2022Difficult to Insert; Activation, Positioning or Separation Problem; Difficult to Insert; Activation, Positioning or Separation Problem

  DURING THE PROCEDURE, THE INTRODUCER NEEDLE WAS NOT MOVING WHICH LED TO A PERFORATION IN THE SUBCLAVIAN VEIN.

  Patient problems: Cardiac Perforation; Vascular Dissection

  MAUDE report 15912790 ↗
• InjuryJun 24, 2022Gas/Air Leak; Gas/Air Leak

  DURING THE IMPLANTATION OF A SINGLE-CHAMBER PACEMAKER WITH AN ELECTRODE IN THE ATRIAL LOCATION, AN AIR EMBOLISM WAS NOTED. WHEN THE TENDRIL ELECTRODE WAS INSIDE THE INTRODUCER, THE ENTRY OF AIR THROUGH THE SHEATH WAS OBSERVED. FOLLOWED BY AN IMMEDIATE DECOMPENSATION OF THE PATIENT WITH OXYGEN SATURATION BELOW 80% AND A BLOOD PRESSURE OF 90/50. VASOACTIVE DRUGS WERE ADMINISTERED WHICH STABILIZED THE PATIENT.

  Patient problems: Air Embolism

  MAUDE report 14804305 ↗