Amplatz G53567Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002535671), received between Apr 3, 2017 and Dec 7, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2018Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 14JAN2019: AS REPORTED, THE CLINICIAN WAS ABLE TO REMOVE THE PIECES FROM THE PATIENT AND PROCEDURE WAS COMPLETED WITH THE USE OF A NEW WIRE. THE PATIENT OUTCOME POST-PROCEDURE WAS LISTED AS "FINE". THE WIRE WAS NOT WITHDRAWN THROUGH A NEEDLE AND DIFFICULTY REMOVING THE WIRE WAS EXPERIENCED BECAUSE THE WIRE WAS BROKEN. CONFIRMATION OF DEVICE RETURN HAS STILL NOT BEEN CONFIRMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8142961 ↗
• MalfunctionSep 24, 2018Unraveled Material; Scratched Material; Unraveled Material; Scratched Material

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902990 ↗
• MalfunctionSep 24, 2018Peeled/Delaminated; Unraveled Material; Peeled/Delaminated; Unraveled Material

  THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902937 ↗
• InjuryApr 3, 2017Material Separation; Material Separation

  DURING A PCNL (PERCUTANEOUS NEPHROLITHOTOMY) PROCEDURE, IT WAS REPORTED THAT AN AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE HAD BROKEN WHILE WITHIN THE PATIENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE WIRE GUIDE WITHOUT DIFFICULTY. HE THEN USED ANOTHER WIRE GUIDE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT ANY DELAY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6452982 ↗