2 Pack, Electrode Delivery Tool Kit 20-0074Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00852184003618), received between Dec 11, 2024 and Dec 11, 2024 — classified as 1 injury.

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 16, 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.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A NEW IMPLANTING SITE FOR USE OF NEURX DIAPHRAGM PACING SYSTEM. THE SYNAPSE BIOMEDICAL CHIEF MEDICAL OFFICER PROVIDED EDUCATIONAL SUPPORT FOR THE SITE'S IMPLANTING TEAM. TWO OPERATIONS WITH IMPLANTATION OF 8 TOTAL ELECTRODES WERE PLANNED AND COMPLETED ON 2 PATIENTS. ONE SURGICAL OPERATION WENT WELL WITH NO DIFFICULTY WITH THE TEAM. ANOTHER MORE COMPLEX PATIENT HAD AN OPERATIVE BLEED REQUIRING RETURNS TO THE OPERATING ROOM TO CONTROL THE BLEEDING. THE PATIENT IN THIS REPORT OF OPERATIVE BLEEDING IS A COMPLEX LUNG TRANSPLANT PATIENT WHO WAS CRITICALLY ILL WITH BILATERAL DIAPHRAGM DYSFUNCTION STILL ON A VENTILATOR REQUIRING SIGNIFICANT RESPIRATORY SUPPORT. PT WAS ON ECMO BECAUSE OF DIFFICULTY WITH OXYGENATION. THE PATIENT ALREADY HAD A SIGNIFICANT RETROPERITONEAL BLEED REQUIRING LAPAROTOMY FROM PLACEMENT OF ECMO JUST DAYS BEFORE WITH DRAINS STILL IN PLACE BECAUSE OF THE RETROPERITONEAL OOZING. THE PATIENT HAD HEPARIN INDUCED THROMBOCYTOPENIA(HITT) COMPLICATING HIS POST LUNG TRANSPLANT COURSE WITH SOME EXTREMITY LOSSES. IT ALSO COMPLICATED THE ANTI-COAGULATION NEEDED FOR ECMO ALONG WITH A NECESSARY DIAPHRAGM PACING OPERATION TO HELP IMPROVE VENTILATION OF HIS LUNGS WITH DIAPHRA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20907080 ↗