Amplatz G53560Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002535602), received between Oct 12, 2016 and May 13, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED AN AMPLATZ EXTRA STIFF PTFE FIXED CORE WIRE GUIDE CAME OUT OF THE CASING AND PART OF IT WAS DAMAGED. THE ISSUE WAS FOUND IN THE UNOPENED PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009592 ↗
• MalfunctionSep 25, 2024Contamination; Contamination

  IT WAS REPORTED THE AMPLATZ EXTRA STIFF PTFE FIXED CORE WIRE GUIDE CONTAINED FOREIGN MATTER DURING IN UNSPECIFIED PROCEDURE. THE FOREIGN MATTER (HAIR) WAS FOUND DURING THE DEVICE PREPARATION WHEN THE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300789 ↗
• MalfunctionMay 10, 2017Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT AMPLATZ EXTRA STIFF PTFE FIXED CORE WIRE GUIDE MALFUNCTIONED DURING AN INTENDED PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE ON A PATIENT. THE MALFUNCTION WAS DESCRIBED AS THE TEFLON COATING OF THE WIRE GUIDE CAME OFF INSIDE THE PATIENT¿S BODY. AN UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. 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 6557176 ↗
• MalfunctionMay 9, 2017Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE AMPLATZ EXTRA STIFF PTFE FIXED CORE WIRE GUIDE MALFUNCTIONED DURING AN INTENDED PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE ON A PATIENT. THE MALFUNCTION WAS DESCRIBED AS THE BLUE TEFLON COATING OF THE WIRE GUIDE CAME OFF INSIDE THE PATIENT¿S BODY. 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 6553549 ↗
• MalfunctionOct 12, 2016Material Fragmentation; Material Fragmentation

  IT WAS REPORTED DURING A PERCUTANEOUS NEPHROSTOLITHOTOMY PROCEDURE FOR STONE REMOVAL THE COATING WAS NOTED TO BE PEELING OFF THE PRODUCT. UPON COMPLETION OF THE PROCEDURE, DURING CHECK UP, THREE SMALL BLUE PARTICLES WHERE SEEN INSIDE THE RENAL PELVIS. THE THREE SMALL BLUE PARTICLES REMAIN INSIDE THE RENAL PELVIS. 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

  MAUDE report 6024198 ↗