Herc Flex 360 Universal Stabilizer Arm T401162Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00699753450943), received between Jun 23, 2021 and Feb 13, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Break; Break

  NEW INFORMATION RECEIVED THAT THE EVENT OCCURRED DURING OTHER - NON CLINICAL ACTIVITY; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694774 ↗
• MalfunctionNov 6, 2023Break; Break

  NEW INFORMATION RECEIVED THAT INDICATES, THE EVENT OCCURRED DURING SETUP, THE PRODUCT WAS CHANGED OUT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT EFFECT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073553 ↗
• MalfunctionApr 24, 2023Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR, THAT DURING CARDIOPULMONARY BYPASS, THE SLEEVE WAS DEFECTIVE. IT IS UNKNOWN WHETHER THERE WAS A DELAY IN 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 HEALTH CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16799085 ↗
• MalfunctionJul 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE ARM LINKS STUCK. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. 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. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207757 ↗
• MalfunctionJun 29, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT, THE LINKS ON ARMS WERE STICKING AND BINDING TOGETHER, AND IT WAS DIFFICULT TO USE AND POSITION. IT IS UNKNOWN WHETHER THERE WAS A DELAY IN 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. THE PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12087850 ↗
• MalfunctionJun 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY NOTICED THE LINKS ON ARMS STICKING AND BINDING TOGETHER AND DIFFICULT TO USE AND POSITION. 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 12078825 ↗
• MalfunctionJun 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE ARM LINKS GOT STUCK AND BOUND TOGETHER AND WERE DIFFICULT TO USE AND POSITION. IT IS UNKNOWN WHETHER THERE WAS A DELAY IN 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 CONSEQUENCES OR IMPACT TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12078738 ↗
• MalfunctionJun 23, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE ARM LINKS GOT STUCK. PER SUBSIDIARY,THE ARM WAS USED WITH 360 STABILIZER ATTACHMENT IN OFF-PUMP CABG. THE FIRST ANASTOMOSIS WAS COMPLETED SUCCESSFULLY AND WHEN THE HANDLE WAS LOOSENED TO REPOSITION THE ARM TO THE SECOND ANASTOMOSIS, THE ARM LINKS BECAME STUCK IN TWO PLACES AND WERE UNABLE TO BE BENT. THE ARM WAS ONCE REMOVED FROM THE RETRACTOR AND CLEANED WITH SALINE, BUT STILL THE STUCK PARTS WERE NOT LOOSENED AND THE STABILIZER WAS UNABLE TO BE REMOVED FROM THE DISTAL CONNECTION OF THE ARM. AFTER THAT, THE STABILIZER WAS SOMEHOW REMOVED FROM THE DISTAL CONNECTION AND THE ARM WAS ATTACHED TO THE RETRACTOR AGAIN TO BE USED THOUGH THE ARM LINKS WERE STILL STUCK. THE ARM WAS NOT REPOSITIONED WHEN THE ARM WAS TENSIONED. IT IS UNKNOWN WHETHER THERE WAS A DELAY IN 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 CONSEQUENCE OR IMPACT TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETES SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053384 ↗