Linear 7.5Fr. 25cc IAB (with APA) 0684-00-0478-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10607567106533), received between Aug 21, 2024 and Aug 21, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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-2223-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Inappropriate Waveform; Gas/Air Leak; Material Deformation; Inappropriate Waveform; Gas/Air Leak; Material Deformation

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A "GAS LOSS" ALARM HAD BEEN HAPPENING FOR OVER AN HOUR. THE CUSTOMER COULD RESUME PUMPING BUT WITHIN 1-2 MINUTES THE ALARM WOULD HAPPEN AGAIN. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THEY HAD ORDERED A CHEST FILM FOR PLACEMENT LOCATION. THERE WAS NO BLOOD OR VISIBLE KINK IN THE HELIUM TUBING. THE GETINGE REPRESENTATIVE OFFERED TROUBLESHOOTING SUGGESTIONS AS IF THE IAB WERE PLACED VIA FEMORAL ARTERY. THEY WERE UNSUCCESSFUL IN RESOLVING THE ALARM. THE IAB STATUS BAR DID NOT FILL FULLY, AND THE IAB PRESSURE WAVEFORM LOOKED ROUNDED, INDICATING A LIKELY KINK IN THE CATHETER. THE ICU NURSE PRACTITIONER WAS CONTACTED AND SPOKE WITH THE PHYSICIAN ABOUT FURTHER STEPS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20022160 ↗