Amplatz G53566Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002535664), received between Jun 27, 2017 and Jun 21, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2018Material Separation; Material Separation

  IT WAS INITIALLY REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY, A AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE SEPARATED WHEN THE PHYSICIAN TRIED TO REMOVE IT FROM THE CATHETER AND PATIENT. ADDITIONAL INFORMATION WAS REQUESTED ON HOW THE SEPARATED PIECE WAS REMOVED AND WE RECEIVED CLARIFICATION THAT THE WIRE UNRAVELED BUT DID NOT "SEPARATE" INTO TWO PARTS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. UPON DEVICE FAILURE ANALYSIS OF THE RETURNED DEVICE IT WAS DISCOVERED, THE DISTAL WELD BALL OF THE WIRE GUIDE WAS MISSING. REQUEST WAS MADE FOR CONFIRMATION THAT THERE WAS NO PORTION OF THE DEVICE LEFT IN THE PATIENT, HOWEVER THE CUSTOMER HAS NOT PROVIDED ANY FURTHER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625755 ↗
• MalfunctionJun 27, 2017Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT AMPLATZ ULTRA STIFF PTFE FIXED CORE WIRE GUIDE MALFUNCTIONED DURING AN INTENDED PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE ON A PATIENT. THE MALFUNCTION WAS DESCRIBED AS THE WIRE SEPARATED FROM THE CORE WHEN REMOVED FROM THE DISPOSABLE TROCAR NEEDLE. IT WAS FURTHER REPORTED THAT THE REMAINING PART OF THE WIRE WAS STUCK INSIDE THE NEEDLE, WHICH WAS REMOVED WITH THE NEEDLE. THE DISPOSABLE TROCAR NEEDLE WAS DISPOSED OFF. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 6669823 ↗