Sensation 7Fr. 40cc IAB with Accessories, US Only 0684-00-0470-01URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10607567109558), received between Aug 13, 2024 and Mar 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Optical Problem; Optical Problem

  IT WAS REPORTED DURING USE THAT INTRA-AORTIC BALLOON(IAB) FIBER OPTIC FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591668 ↗
• MalfunctionJan 6, 2025Fluid/Blood Leak; Off-Label Use; Fluid/Blood Leak; Off-Label Use

  IT WAS REPORTED THAT DURING THE INTRA AORTIC BALLOON (IAB) THERAPY THE CATHETER WAS PLACED THROUGH AN AXILLARY APPROACH, OFF LABLE. WHEN TRYING TO GET THE PATIENT IN A STANDING POSITION FROM SITTING THE IABP BEGAN TO ALARM "CHECK IABP CATHETER" AND BLOOD WAS NOTICED IN THE HELIUM TUBING. THE CATHETER WAS REMOVED WITH NO HARM TO THE PATIENT. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077544 ↗
• MalfunctionAug 13, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PHYSICIAN MET RESISTANCE WHILE INSERTING THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH. THE IAB WAS REMOVED AND A NEW ONE WAS INSERTED WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973401 ↗