Amplatz G09956Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002099562), received between Oct 5, 2017 and Nov 6, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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. 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.

• MalfunctionNov 6, 2025Flaked; Flaked

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487463 ↗
• MalfunctionJan 31, 2024Material Separation; Material Separation

  AS REPORTED, PRIOR TO PATIENT CONTACT FOR THE DIAGNOSTIC PORTION OF AN UNSPECIFIED PROCEDURE, AN AMPLATZ ULTRA-STIFF SUPPORT WIRE GUIDE "FELT GRITTY" UPON OPENING THE PACKAGE. THE WIRE WAS NOT USED. A SECOND AMPLATZ ULTRA-STIFF SUPPORT WIRE GUIDE REPORTEDLY FELT SIMILAR BUT WAS WIPED OFF AND FELT BETTER; THEREFORE, THE SECOND WIRE WAS USED FOR THE PROCEDURE WITHOUT ISSUE. A SECTION OF THE DEVICE DID NOT REMAIN 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18617128 ↗
• MalfunctionNov 2, 2017Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  IT WAS REPORTED THAT THE AMPLATZ ULTRA-STIFF SUPPORT WIRE GUIDES FRAYED AND GOT STUCK IN THE CATHETER HUBS AS WELL AS A CLOSURE DEVICE. THE PHYSICIAN REPORTED THE THEY ENCOUNTERED RESISTANCE DURING PERFORMANCE OF THE COMPLAINT DEVICES, AND HAD TO PULL OUT THE WIRE GUIDES AND CATHETERS TOGETHER. THE WIRE GUIDES WERE REPORTED TO HAVE BUMPY SILVER SPOTS. A SECTION OF THE DEVICE DID NOT REMAIN 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: No Known Impact Or Consequence To Patient

  MAUDE report 6997746 ↗
• MalfunctionOct 5, 2017Material Deformation; Material Deformation

  AN AMPLATZ ULTRA-STIFF SUPPORT WIRE GUIDE WAS USED IN A LOWER EXTREMITY ANGIOGRAM. IT WAS REPORTED THAT THE WIRE WAS OVER THE AORTIC BIFURCATION, AND THE CATHETER WAS ADVANCED OVER THE WIRE WHEN A "BUMP" WAS FELT IN THE MIDDLE OF THE WIRE. THE PHYSICIAN ATTEMPTED TO CUT THE BACK END OF THE WIRE WHICH WAS UNSUCCESSFUL. BOTH PRODUCTS WERE REMOVED AND A NEW WIRE WAS ADVANCED. A SECTION OF THE DEVICE DID NOT REMAIN 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. UPON RETURN OF THE DEVICE, IT WAS NOTED THAT THE COIL IS TO BE SLIGHTLY EXPANDED, THE WIRE WAS SEVERELY KINKED AND NO COATING WAS PRESENT AT 24.0CM FROM THE PROXIMAL END, AND THE COIL WIRES WERE PROTRUDING DUE TO THE SEVERE DAMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6918796 ↗