Linear 7.5Fr. 40cc IAB (INDIA) (with APA) 0684-00-0480-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10607567109725), received between Apr 2, 2021 and Apr 6, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON (IAB) BOX WAS OPENED, THE CUSTOMER FOUND THE STERILE PACKAGING TO BE COMPROMISED AND THE T-HANDLE WAS STUCK TO THE IAB. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618903 ↗
• MalfunctionApr 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB) A LEAK OCCURRED. THE IAB WAS REMOVED AND REPLACED WITH A NEW ONE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607253 ↗