Hercules 3 Universal Stabilizer Arm 45049Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00699753450493), received between Jul 2, 2018 and Jan 23, 2023 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2023Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE RETRACTOR JAMMED, THE EVENT OCCURRED PRE CARDIOPULMONARY BYPASS, WHERE IN THE INSTRUMENTS GETS TESTED PRIOR TO SURGERY, BEFORE THE PATIENT COME INTO THE ROOM. THERE WAS NO DELAY IN THE PROCEDURE, THE PRODUCT WAS CHANGED OUT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY, NO BLOOD LOSS AND WITH NO PATIENT EFFECT.

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

  MAUDE report 16223548 ↗
• MalfunctionAug 24, 2022Defective Device; Defective Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR A BEATING HEART ISSUE. IT IS STILL UNKNOWN WHEN THE EVENT OCCURRED, IF IT RESULTED IN A DELAY IN THE PROCEDURE, IF THE PRODUCT WAS CHANGED OUT OR IF THE SURGERY WAS COMPLETED SUCCESSFULLY, IF IT CAUSED OR CONTRIBUTED TO AN INJURY TO THE PATIENT OR IF THERE WAS A 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.

  Patient problems: Insufficient Information

  MAUDE report 15284542 ↗
• MalfunctionJun 7, 2022Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE LOCKING MECHANISM WAS BROKEN. IT IS STILL UNKNOWN WHETHER THERE WAS A DELAY IN THE PROCEDURE, WHETHER THE SURGERY WAS COMPLETED SUCCESSFULLY AND WHETHER THERE WAS BLOOD LOSS. DUE TO THE UNKNOWN INFORMATION, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. THE PRODUCT WAS CHANGED OUT.

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

  MAUDE report 14620845 ↗
• MalfunctionNov 24, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. THE EVENT OCCURRED DURING CARDIOPULMONARY BYPASS, THERE WAS NO DELAY IN THE PROCEDURE, 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 12868738 ↗
• MalfunctionNov 12, 2021Defective Device; Defective Device

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING SETUP, THE MAIN HANDLE WAS DEFECTIVE. IT IS UNKNOWN IF THERE WAS A DELAY IN THE BEGINNING OR DURING 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 PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804926 ↗
• InjuryApr 29, 2021Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE HERCULES ARM BROKE. MEDWATCH REPORT (MW5100647) WAS RECEIVED FROM THE FDA ON 4/26/2021 REGARDING THIS EVENT. BASED ON THE REPORT THE USER NOTED 4 SMALL PIECES WERE OUTSIDE THE WOUND ON THE BLUE TOWEL. RETRACTOR RETRIEVED OFF THE SURGICAL FIELD ALONG WITH THE 4 LOOSE PIECES AND SEQUESTERED IN CONTAINER. CHEST X-RAY TAKEN PER PROTOCOL TO CONFIRM NO PIECES WERE LEFT INSIDE THE CHEST. NEGATIVE RESULTS GIVEN TO THE DR. PATIENT APPEARS TO SUFFER NO UNTOWARD EFFECTS AT THIS TIME. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11745075 ↗
• MalfunctionApr 15, 2021Positioning Problem; Physical Resistance/Sticking; Positioning Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT INDICATES THAT THE PRODUCT WAS CHANGED OUT. THE UNIT WAS TAKEN OUT OF SERVICE WHEN IT WOULD NOT HOLD POSITION, AND ANOTHER UNIT WAS PUT IN ITS PLACE.

  Patient problems: Insufficient Information

  MAUDE report 11675067 ↗
• MalfunctionJun 8, 2020Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARMS OF THE NYLON WASHERS WERE BROKEN. PER USER FACILITY, THEY EXECUTED EXACTLY THE INSTRUCTIONS GIVEN ON THE IFU AS REGARDS CLEANING, STERILIZATION AND LUBRICATION. THE SURGICAL PROCEDURE WAS POSTPONED DUE TO UNAVAILABILITY OF THE DEVICE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10130113 ↗
• MalfunctionJun 8, 2020Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARMS OF THE NYLON WASHERS WERE BROKEN. PER USER FACILITY, THEY EXECUTED EXACTLY THE INSTRUCTIONS GIVEN ON THE IFU AS REGARDS CLEANING, STERILIZATION AND LUBRICATION. THE SURGICAL PROCEDURE WAS POSTPONED DUE TO UNAVAILABILITY OF THE DEVICE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10130097 ↗
• MalfunctionJun 8, 2020Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE ARMS OF THE NYLON WASHERS WERE BROKEN. PER USER FACILITY, THEY EXECUTED EXACTLY THE INSTRUCTIONS GIVEN ON THE IFU AS REGARDS CLEANING, STERILIZATION AND LUBRICATION. THE SURGICAL PROCEDURE WAS POSTPONED DUE TO UNAVAILABILITY OF THE DEVICE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10130060 ↗
• MalfunctionApr 23, 2020Defective Component; Defective Component

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR, THAT THE HANDLE WON¿T TIGHTEN. IT IS STILL UNKNOWN WHEN THE EVENT OCCURRED, IF IT RESULTED IN A DELAY IN THE PROCEDURE NOR IF IT CAUSED OR CONTRIBUTED TO AN INJURY TO THE PATIENT OR IF THERE WAS A 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.

  Patient problems: No Information

  MAUDE report 9990885 ↗
• MalfunctionNov 27, 2019Break; Break

  NEW INFORMATION RECEIVED THAT, TWO SMALL PIECES OF METAL FOUND ON OUTSIDE OF CHEST, AND NO PIECES FOUND IN PATIENT'S CHEST, CONFIRMED VIA X-RAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9386178 ↗
• MalfunctionNov 27, 2019Fracture; Fracture

  NEW INFORMATION RECEIVED THAT, TWO SMALL PIECES OF METAL FOUND ON OUTSIDE OF CHEST, AND NO PIECES FOUND IN PATIENT'S CHEST, CONFIRMED VIA X-RAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9386108 ↗
• MalfunctionNov 15, 2019Defective Component; Defective Component

  NEW INFORMATION WAS RECEIVED INDICATING THAT THE EVENT OCCUR DURING SETUP. THE PRODUCT WAS CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY NOR ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 9329646 ↗
• MalfunctionSep 16, 2019Break; Break

  NEW INFORMATION RECEIVED THAT THE EVENT OCCURRED DURING SETUP.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9069833 ↗
• MalfunctionMay 22, 2019Collapse; Collapse

  NEW INFORMATION WAS RECEIVED INDICATING THAT THERE WAS A MISUNDERSTANDING ON THE INITIAL ISSUE REPORTED. AS PER USER FACILITY THE CORRECT DESCRIPTION OF THE ISSUE WAS THE DEVICE BEING IMPOSSIBLE TO USE DUE TO HANDLE WAS BLOCKED, AND IT NEVER FELL ON MYOCARDIUM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8634287 ↗
• InjuryJul 12, 2018Sharp Edges; Sharp Edges

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER CARDIOPULMONARY BYPASS, AN ABRASION WAS DISCOVERED ON THE HEART. PER USER FACILITY THE DISTAL END/ LIP OF THE UNIT WAS SHARP/ ABRASIVE AND IT RUBBED AND CREATED AN ABRASION ON THE HEART. THERE WAS A DELAY FOR LESS THAN A MINUTE; PRODUCT WAS CHANGED OUT; PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Injury; Myocardial Contusion

  MAUDE report 7683321 ↗
• InjuryJul 2, 2018Scratched Material; Scratched Material

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE DISTAL END OF THE HERCULES ARM IS SHARP AND ABRASIVE WHICH CAUSED AN ABRASION IN THE HEART WHILE DOING THE PROCEDURE. THERE WAS A ABOUT A 15 MINUTE DELAY TO REPAIR THE ABRASION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME ARM AS IT WAS FIXED BY PUTTING A SEAL ON THE UNIT. *NO BLOOD LOSS, *PRODUCT WAS NOT CHANGED OUT, *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Injury; Myocardial Contusion

  MAUDE report 7656811 ↗