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Kii® Balloon Blunt Tip System C0Q20Recalls & reported problems

Applied Medical Resources Corporation · Class 2

All models of Kii Balloon Blunt Tip System (3)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915124878), received between Jun 22, 2021 and Jun 22, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).

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.

Most reported problems

Device problems

  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJun 22, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: "I RECEIVED 1 C0Q20, THAT HAS A SMALL HOLE IN THE PACKAGING." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 04JUN2021 FROM [NAME]: "THE HOLE WAS NOTICED IN THE OR WHEN THEY WERE PULLING IT FOR A PROCEDURE. THE PRODUCT IS AVAILABLE FOR RETURN." PHOTOS HAVE BEEN PROVIDED. TYPE OF INTERVENTION: NA. PATIENT STATUS: NA - NO PATIENT'S INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12041319 ↗

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Sources and updates

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