PENTAX OE-A51Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04961333123339), received between Feb 5, 2024 and Oct 4, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionOct 4, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  B3: NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER. PER THE INITIAL REPORT, BASED ON BALLOON SALES DATA COLLECTED FROM PENTAX MEDICAL CUSTOMER SERVICE REPRESENTATIVE AND PENTAX MEDICAL JAPAN, IT'S REASONABLE TO CONCLUDE THAT THE EXPIRED BALLOON CAME FROM EG36-J10UR-Q006RZ0032. WHEN THE USER FACILITY RETURNED THE DEVICE DUE TO BEING DEFECTIVE, THE EXPIRED BALLOONS REMAINED ONSITE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20366702 ↗
• MalfunctionFeb 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING THE DEMONSTRATION, THE BALLOON TORE INSIDE THE PATIENT'S BODY. AS A RESULT OF CUSTOMER FEEDBACK, NO PATIENT INCIDENTS NOR FRAGMENT LET INSIDE A PATIENT. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647302 ↗