Aptra BDSD01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850023925022), received between Aug 14, 2024 and Jul 21, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25884688 ↗
• MalfunctionJul 2, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE APTRA SCOPE WAS KINKED OUT OF THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25694724 ↗
• MalfunctionApr 24, 2026

  PLUGGED SCOPE IN AND THERE WAS NO PICTURE, OBTAINED A NEW SCOPE AND OBTAINED AN IMAGE, PROCEEDED WITH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980101 ↗
• InjuryFeb 3, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SCOPE WORKED AND FLEXED NORMALLY IN LEFT URETER. ON THE RIGHT SIDE, THE SURGEON NOTICED THAT THE SCOPE WAS NOT FLEXING SMOOTHLY, BUT IT WORKED. THEN THE SCOPE DID NOT FLEX AT ALL AND BECAME STUCK IN THE URETERAL ACCESS SHEATH THAT WAS IN THE PATIENT'S RIGHT URETER. THEY HAD X-RAY COME IN WITH THE C-ARM. THE DR USED SCISSORS TO CUT THE ACCESS SHEATH. THEN THEY WERE ABLE TO SAFELY REMOVE THE SCOPE UNDER X-RAY. IT LOOKS LIKE THE SCOPE HAD A SLIGHT BREAK IN THE SHEATH. THEY WERE NOT SURE IF IT GOT HUNG UP ON THE ACCESS SHEATH. THE DR WOULD BE A BETTER WITNESS TO EXACT DETAILS. THEY WERE CONFIDENT THAT NO PIECES WERE LEFT BEHIND.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246923 ↗
• MalfunctionJan 21, 2026No Apparent Adverse Event

  UPON PLUGGING IN THEN TURNING ON BOX, LOGOS AND TIME SHOWED ON SCREEN BUT NO IMAGE APPEARED; WE UNPLUGGED AND RE-PLUGGED AND GO THE SAME RESULT. WE OPENED ANOTHER SCOPE AND IT WORKED WITHOUT ISSUE, DETERMINING THE FIRST SCOPE WAS DEFECTIVE.

  Patient problems: Urolithiasis

  MAUDE report 24128833 ↗
• MalfunctionDec 15, 2025No Display/Image

  UPON PLUGGING IN THEN TURNING ON BOX, LOGOS AND TIME SHOWED ON SCREEN BUT NO IMAGE APPEARED; WE UNPLUGGED AND RE-PLUGGED AND GO THE SAME RESULT. WE OPENED ANOTHER SCOPE AND IT WORKED WITHOUT ISSUE, DETERMINING THE FIRST SCOPE WAS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802625 ↗
• MalfunctionAug 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  EVENT TITLE: CONFIDENTIAL DESCRIBE THE EVENT OR PROBLEM: WHILE PERFORMING THE PROCEDURE THE PHYSICIAN WAS USING A RIGID URETEROSCOPE, AND HE FELT IT BREAK. WE OPENED A SINGLE USE DIGITAL FLEXIBLE URETEROSCOPE AND WHILE USING THIS SCOPE AGAIN, HE COMMENTED THAT HE FELT IT BROKE. IT WAS PULLED OUT OF THE PATIENT AND EXAMINED. THE SCRUB TECH ASKED THE PHYSICIAN IF A PIECE COULD HAVE BEEN LEFT BEHIND IN THE PATIENT. HE SAID IF IT DID IT WOULD BE TOO SMALL TO BE SEEN. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? RETROGRADE RENOSCOPIC STONE EXTRACTION WITH LASER LITHOTRIPSY AND STENT EXCHANGE WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

  Patient problems: Insufficient Information

  MAUDE report 19988418 ↗