TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES 0684-00-0608Recalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10607567111728), received between Jan 24, 2022 and Sep 29, 2026 — classified as 2 deaths, 2 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (21 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-2218-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Insert

  It was reported that during an attempt to insert TransRay Plus 40cc balloon catheter, the guidewire could not pass through the catheter. The device was then replaced with another product of the same type and size, which functioned without any issues, allowing the procedure to be completed successfully. No harm to the patient reported. As the patient had an infection, the product was discarded in accordance with hospital policy and the serial number is not available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928160 ↗
• MalfunctionSep 28, 2026Improper Flow or Infusion

  It was reported that after placement of the TransRay Plus 40cc Intra-Aortic Balloon (IAB) catheter, pumping was started. Although it was confirmed on the display that pumping was being performed, the augmentation pressure did not increase at all. Repositioning of the catheter was attempted, but no improvement was observed. Therefore, the device was replaced with a Izumi Kogyo IAB, after which improvement was noted. No harm to the patient was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911787 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak; Leak/Splash

  It was reported that on 31 August at 14:00, a TransRay Plus 40cc Intra-Aortic Balloon (IAB) catheter was inserted and Intra-Aortic Balloon Pump (IABP) support was initiated. The catheter was inserted via the right femoral artery. On 1 September at 9:30 AM, an ¿IAB circuit leak¿ alarm occurred. After removing the extension tube, a syringe was attached to the extracorporeal tubing and negative pressure was applied. Blood backflow was observed, and the event was therefore determined to be a balloon rupture. No blood backflow into the CARDIOSAVE IABP console was observed. The catheter was immediately removed. As the patient's hemodynamics remained stable, IABP therapy was discontinued at that point. No harm to the patient was reported.It was reported that the ¿Gas Loss in IAB Circuit¿ alarm was also displayed on the Cardiosave IABP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865620 ↗
• MalfunctionSep 23, 2026Failure to Advance

  It was reported that during insertion of TransRay Plus 40cc Intra-Aortic Balloon (IAB) catheter malfunctioned. The balloon passed through the sheath, but could not be advanced further from around the area just proximal to the abdominal aorta. After replacing it with a new balloon catheter (TRP4046), the catheter was inserted without any issues. No harm to the patient was reported.Due to patient's pre-existing infection, unrelated to the Getinge device, the IAB was not saved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865229 ↗
• MalfunctionSep 10, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50708043 ↗
• MalfunctionAug 30, 2026Obstruction of Flow

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50514646 ↗
• MalfunctionAug 30, 2026Loss of or Failure to Bond; Failure to Calibrate; Material Deformation; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50513191 ↗
• MalfunctionAug 28, 2026Break; Failure to Calibrate; Device Sensing Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497546 ↗
• InjuryAug 24, 2026Fluid/Blood Leak; Difficult to Remove; Material Rupture; Material Split, Cut or Torn

  N/A

  Patient problems: Insufficient Information; Unspecified Vascular Problem

  MAUDE report 50405557 ↗
• MalfunctionAug 18, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50293295 ↗
• OtherAug 14, 2026Leak/Splash

  It was reported that during preparation for insertion of a TransRay Plus 40cc Intra-Aortic Balloon (IAB) catheter, negative pressure was maintained on the balloon using the supplied one-way valve and a 30 mL syringe while a manual flush was performed through the guidewire inner lumen. During the flush, flushing solution was observed leaking into the balloon interior. The event occurred before the IAB catheter was fully inserted into the patient. The affected catheter was not used, and IABP therapy was successfully completed using another new TransRay Plus 40cc catheter. The intended insertion site was the right femoral artery, and the aortic condition was reported as normal. The guidewire was manufactured by Getinge; the dilator and sheath were manufactured by another company. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251829 ↗
• MalfunctionApr 29, 2026Device Sensing Problem

  IT WAS REPORTED BY THE CUSTOMER THAT IMMEDIATELY AFTER INSERTION OF A TRP4046 CATHETER THE OPTICAL SENSOR FAILED TO OUTPUT PRESSURE, TRIGGERING AN ALARM INDICATING IAB OPTICAL SENSOR MALFUNCTION.THERE WAS NO PATIENT HARM AND INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031386 ↗
• MalfunctionApr 10, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING USE, AFTER INSERTING THE TERUMO 8F SHEATH, WE ATTEMPTED TO INSERT THE IAB CATHETER, BUT THE BALLOON WRAPPING CAME UNDONE, PREVENTING IT FROM PASSING THROUGH THE SHEATH. WE HAD PERFORMED NEGATIVE PRESSURE WORK ON THE BALLOON USING A ONE-WAY VALVE, SO THE BALLOON WRAPPING SHOULD HAVE BEEN DONE PROPERLY. WHEN WE INSERTED ANOTHER TRP4046 CATHETER USING THE SAME PROCEDURE, THE BALLOON WAS SECURELY WRAPPED AND PASSED THROUGH THE SHEATH WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838831 ↗
• MalfunctionApr 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE TRANSRAY PLUS 40CC HAD LEAKAGE ISSUE. AFTER INSERTING THE CATHETER INTO THE SHEATH, BLOOD WAS OBSERVED LEAKING FROM AROUND THE CONNECTION POINT BETWEEN THE SIDE PORT AND THE THREE WAY STOPCOCK OF THE SHEATH. THE TUBE WAS CLAMPED WITH A TUBE CLAMP AND USE IS CONTINUING. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797320 ↗
• MalfunctionApr 1, 2026Difficult to Insert; Positioning Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758961 ↗
• MalfunctionMar 22, 2026Positioning Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24658090 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629105 ↗
• MalfunctionMar 5, 2026Pacing Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518120 ↗
• MalfunctionMar 4, 2026Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504325 ↗
• MalfunctionMar 2, 2026Leak/Splash

  IT WAS REPORTED THAT THE TRANSRAY PLUS 40CC HAD LEAKAGE ISSUE. A LEAK WAS DISCOVERED AT THE CONNECTION POINT OF THE SHEATH INTRODUCER AND THE THREE-WAY STOPCOCK IN THE ICU, SO THE SHEATH INTRODUCER WAS CLAMPED DOWN AND USED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489432 ↗
• MalfunctionMar 2, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE, INTRA AORTIC BALLOON (IAB) SENSOR DID NOT DISPLAY BLOOD PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482384 ↗
• MalfunctionFeb 21, 2026Appropriate Device Problem Term/Code Not Available

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408653 ↗
• MalfunctionFeb 21, 2026Restricted Flow rate

  IT WAS REPORTED BY THE CUSTOMER THAT DURING USE THE TRP4046 INTRA-AORTIC BALLOON (IAB) CATHETER WAS INSERTED PER STANDARD PROCEDURE. DURING ICU MANAGEMENT, INTERMITTENT ¿IAB CATHETER REQUIRES INSPECTION (FLOW RESTRICTION)¿ ALARMS WERE OBSERVED. BALLOON REPOSITIONING UNDER FLUOROSCOPY PROVIDED TEMPORARY RESOLUTION, BUT THE ALARM RECURRED. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408652 ↗
• MalfunctionFeb 15, 2026Difficult to Insert

  IT WAS REPORTED THAT THE TRANSRAY PLUS 40CC HAD ISSUE DURING BALLOON INSERTION. AFTER INSERTING THE SHEATH, AN ATTEMPT WAS MADE TO INSERT THE BALLOON, BUT RESISTANCE WAS ENCOUNTERED AND IT WAS NOT POSSIBLE TO INSERT IT SMOOTHLY. CONCERNS ABOUT LEAKAGE DUE TO RESISTANCE LED TO THE OPENING AND USE OF A NEW BALLOON. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341481 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD HAD ENTERED IN THE SLEEVE OF INTRA AORTIC BALLOON (IAB). THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321361 ↗