Amplatz G11674Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002116740), received between Dec 19, 2017 and Dec 11, 2018 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8152418 ↗
• MalfunctionNov 26, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS INITIALLY REPORTED, THE AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE HAD AN "ABNORMAL SHAPE" WITH AN INTENDED TREATMENT FOR AN AORTIC VALVE STENOSIS DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. THE PHYSICIAN USED ANOTHER WIRE GUIDE TO COMPLETE THE PROCEDURE. UPON RECEIVING THE COMPLAINT DEVICE AT THE MANUFACTURING FACILITY, IT WAS NOTED DURING INVESTIGATION THAT THE SAFETY WIRE WAS BROKEN FROM THE DISTAL WELD. 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 Consequences Or Impact To Patient

  MAUDE report 8102140 ↗
• MalfunctionNov 7, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED, A PHYSICIAN WAS PLANNING TO INSERT A STENT GRAFT INTO THE PATIENT BY APPROACHING FROM THE LEFT FEMORAL ARTERY. WHEN HE WAS SHAPING THE DISTAL END OF THE AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE, IT BECAME ELONGATED. THIS DEVICE NEVER MADE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE TO. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ACCORDING TO THE COMPLAINANT, THE COMPLAINT DEVICE WAS DISCARDED BY THE USER FACILITY. IT IS THEREFORE, NOT AVAILABLE TO ASSIST THE MANUFACTURER WITH THE INVESTIGATION INTO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8047628 ↗
• MalfunctionSep 25, 2018Material Frayed

  IT WAS REPORTED THAT WHEN THE USER ATTEMPTED TO ALTER THE CONFIGURATION OF THE AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE TIP, HE NOTICED THAT IT WAS FRAYED AND DAMAGED. THE PROCEDURE WAS PERFORMED WITH ANOTHER WIRE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7905511 ↗
• MalfunctionSep 24, 2018Material Frayed

  IT WAS REPORTED THAT THE AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE WAS FOUND TO HAVE A FRAYED TIP UPON OPENING THE PACKAGE. IT DID NOT MAKE PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902400 ↗
• MalfunctionSep 20, 2018Deformation Due to Compressive Stress; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) WITH APPROACH FROM THE RIGHT COMMON FEMORAL ARTERY (CFA). HOWEVER, WHEN THE WIRE WAS BEING INSERTED INTO THE SHEATH, IT WAS FOUND TO HAVE A KINK WITH THE INNER WIRE PROTRUDING APPROXIMATELY 4CM FROM THE TIP. THE PROCEDURE WAS CONTINUED WITH ANOTHER WIRE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7896245 ↗
• MalfunctionSep 20, 2018Deformation Due to Compressive Stress; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE WAS FOUND TO BE KINKED NEAR THE TIP WHEN THE PHYSICIAN ATTEMPTED TO ALTER ITS TIP CONFIGURATION, CAUSING THE INNER WIRE TO PROTRUDE FROM THE COIL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7896092 ↗
• MalfunctionJul 13, 2018Material Frayed; Material Frayed

  IT WAS REPORTED, THE AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE WAS TO BE USED FOR AN ENDOVASCULAR ANEURYSM REPAIR. PRIOR TO USE, IT WAS FOUND TO BE FRAYED UPON REMOVAL FROM THE HOLDER. THE COMPLAINT DEVICE NEVER MADE PATIENT CONTACT. IT WAS REPLACED WITH ANOTHER DEVICE. NO PATIENT ADVERSE EFFECT HAS BEEN REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7686958 ↗
• MalfunctionMar 6, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE AT THE DISTRIBUTOR, THE SURFACE OF THE AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE WAS DAMAGED - "FUZZY." UPON RECEIPT OF PHOTOS OF THE COMPLAINT DEVICE, IT WAS SHOWN THAT THE INNER MANDRIL WAS PROTRUDING FROM THE SHAFT OF THE COMPLAINT DEVICE. THE DEVICE DID NOT COME INTO CONTACT WITH A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7317447 ↗
• MalfunctionDec 19, 2017Break; Break

  THE USER FACILITY REPORTED PRIOR TO USE, THE CORE WIRE BECAME PROTRUDED FROM THE WIRE GUIDE DURING THE SHAPING OF THE WIRE GUIDE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7132734 ↗