Linear 7.5Fr. 25cc IAB with Accessories, US Only 0684-00-0478-01URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10607567109480), received between Sep 3, 2021 and Sep 17, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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-2223-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237697 ↗
• MalfunctionSep 6, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY ONE MONTH OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE NURSE NOTICED FROTHY BLOOD IN THE GAS CHAMBER OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THERE WERE NO ALARMS NOTED ON THE IABP, BUT IT WAS IMMEDIATELY PLACED IN STAND-BY. A NEW IAB WAS INSERTED TO CONTINUE THERAPY. THERE WAS NO REPORTED INJURY OR ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15364215 ↗
• MalfunctionOct 18, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER 9 DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, A LEAK OCCURRED AND BLOOD WAS SEEN IN THE TUBING. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE IAB WAS REMOVED AND NOT REPLACED BECAUSE THE PATIENT WAS STABLE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647477 ↗
• MalfunctionSep 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A LEAK OCCURRED AND BLOOD WAS SEEN IN THE TUBING. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE ALARM HISTORY OF THE CONSOLE SHOWED SEVERAL CATHETER ALARMS THAT ARE RELATED TO A CATHETER THAT HAD A MINOR LEAK. THE ALARMS INCLUDED AUTO-FILL FAILURE, IAB DISCONNECTED, AND IAB CATHETER RESTRICTION. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12424760 ↗