ManoScan 3885Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260167480954), received between May 24, 2019 and Jan 8, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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.

• InjuryJan 8, 2020Deflation Problem; Deflation Problem

  ACCORDING TO THE REPORTER, WHEN THEY REMOVED THE CATHETER AFTER THE PROCEDURE, THE BALLOON WAS NOT DEFLATED EVEN THOUGH THE SOFTWARE SHOWED THERE WAS NO PRESSURE ON THE BALLOON AND THE BALLOON WAS DETACHED AND REMAINED WITH THE PATIENT. THEY THOUGHT THAT THE PATIENT'S ANATOMY WAS THE ISSUE WHICH CAUSED AN AIRLOCK WITHIN THE SYRINGE. THE PATIENT SUBSEQUENTLY DID HAVE A FLEXIBLE SIGMOIDOSCOPY TO RETRIEVE THE DEFLATED, DETACHED BALLOON. THE CATHETER WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO USER HARM.

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 9567293 ↗
• MalfunctionMay 24, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE SHEATH BALLOON BROKE OF THE CATHETER WHEN DOCTOR REMOVED IT FROM THE PATIENT WITH 30CC OF AIR STILL IN THE BALLOON. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON FROM THE PATIENT WITHOUT SUCCESS AND ADVISED THAT THE BALLOON WILL PASS. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 8640776 ↗