PENTAX OF-A67Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04961333113545), received between Jul 1, 2021 and Jul 24, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K130247); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  BRAND NEW US-BALLOONS LEAKY. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222559 ↗
• MalfunctionJul 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  DEFECTIVE ULTRASOUND-BALLOONS. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222514 ↗
• MalfunctionJul 1, 2021Material Split, Cut or Torn; Material Puncture/Hole; Gas/Air Leak; Material Split, Cut or Torn

  THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. THERE ARE SMALL HOLES IN THE RUBBER. THE BALLOONS ARE LEAKY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12098178 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130247. One submission often covers many models, so check the product and lot details in each record.

• Z-3068-2017 · May 23, 2017 · Terminated
  Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PE