MEGA 7.5 Fr. 40cc IAB W/O Statlock - INDIA 0684-00-0295-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10607567111339), received between Jun 7, 2021 and Apr 17, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 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-2219-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Material Rupture; Material Rupture

  N/A

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854969 ↗
• MalfunctionNov 21, 2023Inflation Problem; Inflation Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187398 ↗
• MalfunctionJun 1, 2023Component Missing; Component Missing

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038109 ↗
• MalfunctionAug 8, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY 30 MINUTES OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED A LEAK IN IAB CIRCUIT ALARM AND BLOOD WAS SEEN IN THE HELIUM TUBING. AFTER REMOVAL, IT WAS FOUND THAT THE INNER LUMEN WAS BROKEN. A NEW IAB WAS INSERTED TO CONTINUE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15187314 ↗
• MalfunctionJun 7, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER THE INSERTION OF THE INTRA-AORTIC BALLOON (IAB), THE IAB WAS NOT AUGMENTING AND COULD NOT INFLATE. THE CONSOLE GENERATED CHECK IAB CATHETER ALARM. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11949442 ↗