Bardia 123622CERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741171819), received between Feb 27, 2026 and Mar 7, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2026 DUE TO 'GROSS HEMATURIA FOR 5 DAYS.' THE MEDICAL ORDER WAS TO PERFORM PERCUTANEOUS BLADDER ARTERY EMBOLIZATION UNDER LOCAL ANESTHESIA, TRANSCATHETER INTERNAL ILIAC ARTERY EMBOLIZATION AND ILIAC ARTERY ANGIOGRAPHY ON (B)(6) 2026, WITH FOLEY CATHETER RETENTION AND CONTINUOUS BLADDER IRRIGATION. WHILE THE NURSE WAS CHECKING THE PATIENT'S DRAINAGE DURING WARD ROUNDS, IT WAS FOUND THAT THE CATHETER HAD OBVIOUSLY SLID OUT. UPON ASKING, THE PATIENT REPORTED THAT AT 14:00, THEY FELT AN UNUSUAL SOUND INSIDE THEIR BODY. A DOCTOR WAS CALLED TO CHECK THE CATHETER AND FOUND THAT THE BALLOON HAD RUPTURED, BUT A CAREFUL EXAMINATION SHOWED THE RUPTURED PART WAS INTACT WITH NO DEFECTS. THE DOCTOR SUGGESTED CONTINUING CATHETER RETENTION, BUT THE PATIENT REFUSED. THE PATIENT'S URINATION AND OTHER CONDITIONS WERE SUBSEQUENTLY OBSERVED, AND NO CATHETERIZATION WAS PERFORMED FOR THE TIME BEING, ENCOURAGING THE PATIENT TO URINATE INDEPENDENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24540821 ↗
• MalfunctionFeb 27, 2026Material Rupture

  IT WAS REPORTED THAT TEN DAYS AFTER THE PATIENT'S PROSTATECTOMY, AN INDWELLING FOLEY CATHETER WAS LEFT IN PLACE DURING SURGERY. ON THE AFTERNOON OF (B)(6) 2026, DURING THE DOCTOR'S ROUNDS, IT WAS FOUND THAT THE CATHETER HAD SLIPPED OUT ON ITS OWN. UPON INSPECTION, IT WAS DISCOVERED THAT THE CATHETER BALLOON WAS RUPTURED, CAUSING THE FLUID INSIDE THE BALLOON TO LEAK OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470807 ↗