Aprima G52963Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002529632), received between Dec 5, 2014 and Dec 5, 2014 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2014Material Separation

  DURING A BILIARY DRAINAGE INSERTION ON A FEMALE PATIENT, THE PHYSICIAN HAD INSERTED THE 22 G CHIBA NEEDLE PERCUTANEOUSLY AND HE PUT THE GUIDE WIRE INTO IT IN ORDER TO PERFORM THE SELDINGER TECHNIQUE. HE TWISTED THE GUIDE WIRE IN ORDER TO ENTER IN A BRANCH OF THE BILIARY TREE, BUT AFTER SEVERAL ATTEMPTS, THE TIP OF THE WIRE SNAPPED, REMAINING WITHIN THE BODY. THE DOCTOR LEFT THE TIP INSIDE IN ORDER NOT TO TAKE FURTHER RISKS. THE DOCTOR IS UNSURE ABOUT LOT HE USED BUT HE ALSO USED ANOTHER LOT (1820334-2014-00607) DURING THE PROCEDURE. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT'S BODY. AFTER 4 DAYS, THE PHYSICIAN PERFORMED ANOTHER PROCEDURE AS THE PATIENT NEEDED TO RECEIVE A BILIARY DRAINAGE INSERTION DUE TO JAUNDICE. DURING THIS PROCEDURE AS THE PHYSICIAN GAINED ACCESS TO BILIARY TREE HE RETRIEVED THE GUIDE WIRE PIECE WITH A LOOP RETRIEVAL CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign body, removal of

  MAUDE report 4335999 ↗