Byrd G19859Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002198593), received between Dec 8, 2022 and Jul 30, 2026 — classified as 2 injuries.

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.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  The following information was received from Merit Medical on behalf of the user facility: A male patient in his 50s with a persistent left superior vena cava (PLSVC) had an atrial lead and a ventricular lead implanted via the right subclavian vein. The ventricular lead was a dual-coil defibrillation lead positioned in the middle cardiac vein. Both leads were screw-in leads. The procedure was performed to replace only the atrial lead. The atrial lead was grasped near its tip using a Needle's Eye Snare (NES002), followed by extraction with an Evolution Shortie (EVNSH11). A 14 Fr laser sheath and subsequently a Byrd Dilator Sheath (PPLBES 10 Fr sheath) were then utilized, and the atrial lead was successfully removed. After the extraction, while attempting to implant a new atrial lead, pericardial effusion was observed. Pericardial drainage was performed, and the patient's condition stabilized. Therefore, surgical intervention via thoracotomy was not required.

  Patient problems: Pericardial Effusion

  MAUDE report 50094063 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT PACEMAKER LEAD EXTRACTION. THE PACEMAKER WAS PLACED ON LEFT CHEST, THE LEADS WERE PLACED TO RIGHT ATRIUM (RA) AND RIGHT VENTRICLE (RV) FROM LEFT SUBCLAVIAN VEIN. WHEN EXTRACTION OF THE LEAD WHICH WAS PLACED IN RA AROUND SUPERIOR VENA CAVA (SVC) USING LR-PPLBES-10.0 (LOT: N186168), THE TIP OF THE LEAD CAME OFF FROM THE RA. AFTER FOR A WHILE IT WAS NOTICED THAT THE BLOOD PRESSURE WENT DOWN GRADUALLY. THE PROCEDURE MOVED TO OPEN SURGERY, IT WAS SUTURED THE TEAR AREA ON RA AND CLOSED THE CHEST. THEN, RV LEAD WAS REMOVED USING LASER SHEATH 12FR AND 14FR (PHILIP) TO COMPLETE THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 15939098 ↗