Flexon 88862589-63Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521103733), received between Jan 29, 2019 and Jan 12, 2023 — classified as 2 deaths, 1 injury, 3 malfunctions.

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

• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN AORTIC VALVE CHANGE, WHEN PLACING THE SUTURE AT THE CARDIAC VEIN, DUE TO THE CALIBER OF THE PACEMAKER WIRE, A LACERATION OF THE MAJOR CARDIAC VEIN WAS CAUSED IN THE POSTERIOR OF THE LEFT VENTRICLE, RESULTING IN ABUNDANT BLEEDING AND SUBSEQUENT PACKAGING. HOURS LATER, THE PATIENT UNDERWENT TWO RE-INTERVENTIONS AND ONE RE-INTERVENTION ON THE NEXT DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 16151212 ↗
• MalfunctionDec 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE WIRE BREAKS WHERE THE WIRE CONNECTS TO THE GROUNDING POST.

  Patient problems: Insufficient Information

  MAUDE report 16071434 ↗
• MalfunctionDec 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A PEDIATRIC CARDIAC PROCEDURE, THE WIRE BREAKS WHERE THE WIRE CONNECTS TO THE GROUNDING POST.

  Patient problems: Insufficient Information

  MAUDE report 16062798 ↗
• DeathAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE CORONARY ARTERY BYPASS GRAFTING ON THE 5TH DAY WHEN THE PATIENT WAS BEING READIED TO BE DISCHARGED AND THE EPICARDIAL PACING WIRES WERE DISCONTINUED, SHORTLY THEREAFTER THE PATIENT COMPLAINED OF NOT FEELING WELL AND BECAME DIAPHORETIC. HYPOTENSION ALSO DEVELOPED POST-WIRE REMOVAL AND CARDIAC RHYTHM CHANGE NOTED AS WELL. THE PATIENT WAS PULSELESS AND ADVANCE CARDIAC LIFE SUPPORT WAS INITIATED, PULSE RETURNED AND PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE HIS CHEST WAS OPENED AND EPINEPHRINE WAS DIRECTLY DELIVERED TO THE HEART. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND WASHED OUT/CLOSED CHEST AND RETURNED TO THE INTENSIVE CARE UNIT WHERE HE WAS LATER DIAGNOSED WITH ANOXIC BRAIN INJURY. CARE WAS WITHDRAWN IN COLLABORATION WITH THE FAMILY.

  Patient problems: Arrhythmia; Death; Diaphoresis; Loss Of Pulse; Low Blood Pressure/ Hypotension; No Code Available

  MAUDE report 8883534 ↗
• DeathAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POST OPERATIVE A CORONARY ARTERY BYPASS GRAFTING, THERE WERE NO POST OPERATIVE COMPLICATIONS, READYING FOR DISCHARGE THE EPICARDIAL PACING WIRE WERE PULLED AND THE PATIENT IMMEDIATELY SUFFERED CARDIAC ARREST AND DID NOT RECOVER DESPITE CHEST RE-ENTRY AND OPEN CARDIAC MASSAGE IMMEDIATELY AFTER ARREST.

  Patient problems: Cardiac Arrest; Death; No Code Available

  MAUDE report 8876491 ↗
• MalfunctionJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, AFTER PENETRATING THROUGH THE TISSUE, THE NEEDLE AND THE THREAD DISENGAGED EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8284610 ↗