Herc Flex Universal Stabilizer Arm T401163Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00699753450950), received between May 19, 2021 and Dec 11, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 2, 2021Terminated

   There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

   Z-1367-2021 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Break; Break

  NEW INFORMATION RECEIVED REGARDING THE USER FACILITY¿S CLEANING/STERILIZATION PROCESSES. CLEANING AGENTS WERE USED ON THIS DEVICE. ALKALINE, NON-FOAMING CLEANER FOR A SPRAY-TYPE WASHING MACHINE. NEUTRAL, BLOOD-DISSOLVING IMMERSION CLEANER. THE CLEANING PROCESS: AFTER A 10-MINUTE IMMERSION IN THE CLEANER, THE FOLLOWING CLEANING PROCESS IS PERFORMED. [P1: HOT WATER DISINFECTION ¿ MILK ¿ DRY]. PRE-CLEANING: 3 MINUTES, CLEANING: 10 MINUTES AT 40 °C (ADD CLEANER) + HEAT DISINFECTION AT 93°C (A0=3000) RINSE: 1 MINUTE, RINSE: 1 MINUTE, FINAL RINSE: 1 MINUTE AT 80 °C (ADD MILK) DRY: 25 MINUTES AT 110 °C. IT TOOK 8 MINUTES IN AN AUTOCLAVE AT 135 °C FOR THEIR STERILIZATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782384 ↗
• InjuryDec 11, 2025Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE HERC FLEX ARM CAME APART. THE PRODUCT WAS TAKEN OFF THE FIELD AND ASSESSED FOR THE SMALL PIECES OF METAL THAT BROKE OFF. AN XRAY WAS TAKEN TO MAKE SURE THERE WAS NO PIECES LEFT BEHIND. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY WITH A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782145 ↗
• MalfunctionNov 26, 2025Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER CARDIOPULMONARY BYPASS, WHEN THE ARM WAS LOOSENED AFTER THE SURGERY, THE RED NYLON WASHER WAS FOUND TO HAVE CRACKED AND A PART OF THE NYLON WASHER FELL ONTO THE DRAPE. THE FALLEN PART WAS RETRIEVED AND MOVED FOR CLEANING, BUT IT WAS DISCOVERED THAT ONE OF THE BALLS FROM THE NYLON WASHER WAS MISSING. THE PATIENT UNDERWENT A CT SCAN; HOWEVER, THE RESULTS ARE UNKNOWN. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657841 ↗
• MalfunctionOct 16, 2023Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE LOCKING MECHANISM WAS BROKEN. AS PER THE USER FACILITY, THE EVENT CAUSED A DELAY, DUE TO THE INTERVENTION IN RETRIEVING THE BROKEN COMPONENTS FROM THE SURGICAL FIELD. *THERE WAS AN UNKNOWN MINUTES OF DELAY. *PRODUCT WAS CHANGED OUT. *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17944600 ↗
• MalfunctionFeb 14, 2023Defective Device; Defective Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE ARM LINKS STUCK. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, WHETHER THERE WAS A DELAY IN THE PROCEDURE, WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THE SURGERY WAS COMPLETED SUCCESSFULLY, OR IF THERE WAS ANY EFFECT ON THE PATIENT RESULTS OF THE SURGERY, OR BLOOD LOSS. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. AS PER THE USER FACILITY, THE LOCK LEVER FOR THE CLAMPING PART IS DEFECTIVE AND THE END TIP WILL NOT MOVE. THE FIRST HANDLE WAS WITH LOOSE LOCK AND THE SECOND UNIT CANNOT HOLD A RAKE RETRACTOR.

  Patient problems: Insufficient Information

  MAUDE report 16371937 ↗
• MalfunctionFeb 14, 2023Defective Device; Defective Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE ARM LINKS STUCK. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, WHETHER THERE WAS A DELAY IN THE PROCEDURE, WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THE SURGERY WAS COMPLETED SUCCESSFULLY, OR IF THERE WAS ANY EFFECT ON THE PATIENT RESULTS OF THE SURGERY, OR BLOOD LOSS. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. AS PER THE USER FACILITY, THE LOCK LEVER FOR THE CLAMPING PART IS DEFECTIVE AND THE END TIP WILL NOT MOVE. THE FIRST HANDLE WAS WITH LOOSE LOCK AND THE SECOND UNIT CANNOT HOLD A RAKE RETRACTOR.

  Patient problems: Insufficient Information

  MAUDE report 16371916 ↗
• MalfunctionJun 7, 2022Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THEY NOTICED A BREAKAGE ON THE LOCKING PLATE. PER USER, WHEN THE STABILIZER ARM WAS ATTEMPTED TO BE SET TO A STERNAL RETRACTOR, THE LOCKING PLATE CAME OFF AND WAS BROKEN. HOWEVER IT IS UNKNOWN IF THE ISSUE CAUSED ANY DELAY TO THE PROCEDURE. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14618552 ↗
• MalfunctionMar 23, 2022Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE RETENTION CLIP WAS BROKEN. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 13870526 ↗
• MalfunctionJun 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE ARM LINKS WERE STICKING AND BINDING. IT IS UNKNOWN IF THE ISSUE CAUSED ANY DELAY TO THE PROCEDURE. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12078855 ↗
• MalfunctionMay 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE ARM LINKS STUCK. IT IS UNKNOWN IF THE ISSUE CAUSED ANY DELAY TO THE PROCEDURE. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. DURING THE PROCEDURE, THE ARM WAS DISCONNECTED FROM THE RETRACTOR. WHEN THE ARM WAS CONNECTED TO THE RETRACTOR AGAIN, THE ARM LINKS WERE FOUND TO BE STUCK. THE ARM LINKS WERE RELEASED USING HAMMER AND USED TO CONTINUE THE PROCEDURE. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847989 ↗