YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT 0684-00-0559-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10607567107585), received between Nov 4, 2020 and Aug 18, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 23, 2023Class IIOpen, Classified

   During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

   Z-2216-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• OtherAug 18, 2026Failure to Advance

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50294387 ↗
• MalfunctionMar 4, 2026Inflation Problem

  IT WAS REPORTED THAT AFTER THE IABP WAS PLACED IN THE DESCENDING AORTA AND THE PUMP WAS STARTED, THE INTRA-AORTIC BALLOON (IAB) FAILED TO EXPAND. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504811 ↗
• MalfunctionFeb 6, 2026Unraveled Material; Positioning Problem

  IT WAS REPORTED THAT THE YAMATO PLUS R INTRA AORTIC BALLOON (IAB) HAD DIFFICULTY WITH BALLOON CATHETER INSERTION DUE TO RESISTANCE WHEN USING THE SUPPLIED SHEATH. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277254 ↗
• MalfunctionJan 12, 2026Leak/Splash; Material Rupture

  IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE INTRA-AORTIC BALLOON (IAB) A BALLOON RUPTURE AND THE IAB CIRCUIT INSPECTION ALARM SOUNDED MULTIPLE TIMES, AND BLOOD WAS OBSERVED INSIDE THE CATHETER SHAFT. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032081 ↗
• MalfunctionNov 17, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING USE, THE INTRA-AORTIC BALLOON (IAB) CATHETER WAS INSERTED INTO THE ATTACHED SHEATH. IMMEDIATELY AFTER INSERTING THE SHEATH, THE BALLOON CATHETER BECAME DIFFICULT TO INSERT DUE TO TORTUOSITY OF THE BLOOD VESSEL. SINCE THERE WAS NO ALTERNATIVE ANOTHER IAB CATHETER WAS INSERTED, WHICH MADE IT POSSIBLE TO INSERT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572203 ↗
• MalfunctionNov 7, 2025Migration; Migration

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON PLACEMENT POSITION WAS CHECKED BY ANGIOGRAPHY, IT WAS DETERMINED THAT THE BALLOON WAS IN THE WRONG POSITION, AND ATTEMPTS WERE MADE TO ADJUST THE POSITION, BUT THIS WAS NOT SUCCESSFUL AND THE BALLOON WAS REMOVED. WHEN THE REMOVED BALLOON CATHETER WAS CHECKED, THE POSITION OF THE PROXIMAL MARKER ON THE CONTRAST MARKER WAS FOUND TO HAVE SHIFTED. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494517 ↗
• MalfunctionOct 15, 2025Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23298400 ↗
• MalfunctionSep 11, 2025Positioning Problem; Positioning Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025302 ↗
• MalfunctionSep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER AFTER INSPECTION THAT INTRA-AORTIC BALLOON (IAB) THE BLOOD WAS CONFIRMED TO BE BEING DRAWN INTO THE EXTENSION TUBE OF THE IAB CATHETER. NO INJURY AND HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002784 ↗
• MalfunctionJun 3, 2025Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  IT WAS REPORTED THAT DURING THE INTRA-AORTIC BALLOON THERAPY, THE BALLOON DID NOT EXPAND.

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

  MAUDE report 22130429 ↗
• MalfunctionMar 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE CARDIAC EMERGENCY AND AFTER SURGERY THE YAMATO PLUS-R 30CC INTRA-AORTIC BALLOON (IAB) WITH ACCESSORIES AND RETRACTION KIT WAS REMOVED TO STABILIZE THE PATIENT'S CONDITION, BUT BLOOD WAS DRAWN INTO THE BALLOON. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685681 ↗
• MalfunctionFeb 18, 2025Inappropriate Waveform; Inappropriate Waveform

  IT WAS REPORTED THAT DURING TREATMENT WITH THE INTRA-AORTIC BALLOON PUMP (IABP), THE BLOOD PRESSURE WAVEFORM OF THE INTRA-AORTIC BALLOON (IAB) SOMETIMES BECAME STRANGE AND JAGGED.

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

  MAUDE report 21399733 ↗
• MalfunctionJan 13, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INTRA AORTIC BALLOON HAD AN ISSUE WHILE PREPARING TO INSERT THE BALLOON CATHETER (YMT30R) INTO AN AMI PATIENT, THE WRAPPING CAME UNDONE AS SOON AS THE BALLOON WAS PULLED OUT OF THE T-HANDLE AFTER SUFFICIENT NEGATIVE PRESSURE WAS APPLIED. ALTHOUGH IT WAS REWRAPPED BY HAND, IT COULD NOT BE INSERTED INTO THE SHEATH. AS THE PATIENT'S CONDITION WAS POOR, THE HOSPITAL TRIED A PRODUCT OF THE SAME TYPE AND SIZE AND WERE ABLE TO COMPLETE THE PROCEDURE FROM INSERTION TO PUMPING WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21135485 ↗
• MalfunctionDec 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT IMMEDIATELY AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB), AT AROUND 7:00 AM ON (B)(6) 2024, IT WAS NOTICED THAT THE IAB DID NOT EXPAND. EVEN AFTER CHANGING THE PUMP, THE SITUATION DID NOT CHANGE. THE IAB WAS THEN REPLACED AND PUMPING BEGAN NORMALLY AND THERAPY WAS COMPLETED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836284 ↗
• MalfunctionOct 30, 2024Inability to Auto-Fill; Difficult to Insert; Inability to Auto-Fill; Difficult to Insert

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570200 ↗
• MalfunctionNov 14, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED AND THERAPY WAS INITIATED, A CHECK IAB CATHETER ALARM WAS GENERATED AND THERAPY COULD NOT BE STARTED. THE IAB WAS REMOVED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130629 ↗
• MalfunctionNov 1, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, AT 1:30, DURING INTRA-AORTIC BALLOON (IAB) THERAPY ON A PATIENT WITH ACUTE MYOCARDIAL INFARCTION (AMI), THE IAB MEMBRANE WOULD NOT INFLATE WHILE BEING USED ON A CS300 INTRA-AORTIC BALLOON PUMP (IABP). THE HOSPITAL STAFF ATTEMPTED TO RESTART THE PROCEDURE SEVERAL TIME, BUT THE PROBLEM PERSISTED. SINCE THE ISSUE COULD NOT BE RESOLVED, THE INSERTED IAB WAS REMOVED AND PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS COMPLETED WITHOUT IABP SUPPORT. FLUOROSCOPY SHOWED THAT THE BALLOON WAS NOT COMING OUT OF THE SHEATH. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048456 ↗
• MalfunctionOct 2, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) HAD AN ABNORMAL POSITION OF THE X-RAY MARKER. IT WAS NOTED THAT THE PATIENT HAD BEEN TRANSFERRED IN FROM ANOTHER FACILITY. AFTER CHECKING THE FLUOROSCOPIC IMAGE, IT APPEARED THAT THE MARKER ON THE BASE SIDE OF THE IAB HAD MOVED TOWARD THE TIP OF THE IAB. THE IAB WAS THEN REMOVED. UPON INSPECTION, THE PHYSICIAN NOTED THAT IT SEEMED AS THOUGH THERE WAS AN OPAQUE MARKER INSIDE THE IAB. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852176 ↗
• InjuryNov 4, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER INSERTION OF THE INTRA-AORTIC BALLOON(IAB), THERE WAS A LOT OF BLEEDING. THE BLEEDING SITE WAS CONFIRMED, BLOOD LEAKED FROM THE TIP OF THE HUB OF THE SHEATH. SINCE IT CONTINUED TO LEAK CONTINUOUSLY, IAB'S STAT GUARD TIP WAS PUSHED INTO THE SHEATH HUB TO REDUCE THE AMOUNT OF BLEEDING. THE CATHETER WAS REMOVED ON (B)(6) 2020.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10786562 ↗