Sensation 7Fr. 40cc IAB (INDIA) 0684-00-0470-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10607567109749), received between Oct 24, 2022 and Apr 24, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 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-2217-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS INITIATED ON INTRA AORTIC BALLOON PUMP (IABP) SUPPORT WITH 40 CC SENSATION BALLOON CATHETER. AFTER INSERTION AND CONNECTION TO THE IABP CONSOLE, NO ARTERIAL PRESSURE SIGNAL WAS DETECTED FROM IAB. A PERSISTENT IAB OPTICAL SENSOR FAILURE ALARM INDICATED MALFUNCTION OF THE FIBER OPTIC PRESSURE SENSING SYSTEM. IABP SUPPORT WAS CONTINUED IN ECG TRIGGER MODE USING THE SAME BALLOON CATHETER TO MAINTAIN SYNCHRONIZATION WITH THE CARDIAC CYCLE. ARTERIAL BLOOD PRESSURE WAS MONITORED VIA AN ALTERNATE INVASIVE ARTERIAL LINE CONNECTED TO THE BEDSIDE MONITOR. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983119 ↗
• MalfunctionJul 24, 2023Inflation Problem; Leak/Splash; Pressure Problem; Inflation Problem; Leak/Splash; Pressure Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379151 ↗
• MalfunctionJul 12, 2023Inability to Auto-Fill; Inflation Problem; Material Deformation; Inability to Auto-Fill; Inflation Problem; Material Deformation

  IT WAS REPORTED THAT AFTER INSERTION, THE CONSOLE GENERATED AN AUTOFILL FAILURE ALARM AND THE INTRA-AORTIC BALLOON (IAB) WAS NOT ABLE TO INFLATE. THE CUSTOMER FOUND A KINK IN MIDDLE OF THE IAB. A NEW IAB WAS INSERTED TO CONTINUE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309521 ↗
• MalfunctionNov 22, 2022Difficult to Insert; Difficult to Insert

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845809 ↗
• MalfunctionOct 24, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUSTOMER ATTEMPTED A SHEATH-LESS INSERTION OF THE INTRA-AORTIC BALLOON (IAB) AND FOUND BLOOD INSIDE THE CENTRAL LUMEN. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663562 ↗