Sensation 7Fr 40cc IAB with Accessories (Turkey) 0684-00-0470-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10607567113135), received between Jan 15, 2025 and Sep 10, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Failure to Advance; Material Deformation

  It was reported that during use, while placing the Sensation 40cc balloon catheter, the user stated that the catheter failed to advance due to damage to the distal tip and that the procedure was continued with a new catheter. The IAB inserted prior to surgery could not be withdrawn when removal was attempted during the procedure. Examination after removal revealed damage to the distal tip. Surgical intervention was not required for the balloon catheter removal. No harm to the patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50710095 ↗
• MalfunctionJan 15, 2025Overheating of Device; Failure to Sense; Overheating of Device; Failure to Sense

  IT WAS REPORTED THAT DURING INTRA AORTIC BALLOON THERAPY (IAB) "FIBER OPTIC SENSOR FAILURE" WARNING APPEARED ON THE SCREEN. THE USER'S REASON FOR CALLING WAS THE "NO PRESSURE SOURCE AVAILABLE" WARNING. THERE WAS NO PATIENT HARM/INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21156927 ↗