Amplatz G11684Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002116849), received between Jul 12, 2017 and Sep 24, 2018 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2018Deformation Due to Compressive Stress; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE BECAME KINKED DURING PREPARATION WHEN THE PHYSICIAN ATTEMPTED TO RESHAPE THE TIP, CAUSING THE INNER WIRE TO PROTRUDE FROM THE COIL. 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 Known Impact Or Consequence To Patient

  MAUDE report 7901892 ↗
• MalfunctionSep 24, 2018Material Frayed

  IT WAS REPORTED THAT THE SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE WAS FOUND TO BE FRAYED AND FUZZY 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 Known Impact Or Consequence To Patient

  MAUDE report 7901672 ↗
• MalfunctionSep 24, 2018Material Deformation

  IT WAS REPORTED THAT THE SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE BECAME KINKED AT THE TIP WHEN THE PHYSICIAN ATTEMPTED TO ALTER ITS TIP CONFIGURATION, CAUSING THE INNER WIRE TO PROTRUDE FROM THE COIL. IT DID NOT MAKE PATIENT CONTACT, BUT THE SAME ISSUE OCCURRED WITH TWO MORE REPLACEMENT DEVICES OF THE SAME LOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7901577 ↗
• MalfunctionSep 21, 2018Material Separation; Deformation Due to Compressive Stress; Material Protrusion/Extrusion

  THE COMPLAINANT REPORTED THAT THERE WAS A KINK IN THE OUTER COIL ON THE TIP OF THE SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE. THE CORE WIRE ALSO APPEARED TO BE PROTRUDED. THE TAVI (TRANSCATHETER AORTIC VALVE IMPLANTATION) PROCEDURE WAS BY TRANSFEMORAL APPROACH, AND IT WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME LOT. IT WAS FURTHER NOTED THAT THE DISTAL WELD CONNECTION WAS DISCOVERED TO HAVE SEPARATED FROM THE COIL AND SAFETY. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7898239 ↗
• MalfunctionSep 20, 2018Material Protrusion/Extrusion

  IT WAS REPORTED THAT WHEN THE USER ATTEMPTED TO SHAPE THE TIP OF THE SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE, ITS CORE WIRE PROTRUDED FROM THE COIL. IT DID NOT MAKE PATIENT CONTACT, AND ANOTHER DEVICE OF THE SAME LOT WAS USED, BUT THE ISSUE OCCURRED AGAIN. THE PROCEDURE WAS COMPLETED WITH A THIRD DEVICE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7896186 ↗
• MalfunctionSep 20, 2018Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT THE SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE BECAME KINKED 5CM FROM THE TIP WHEN THE PHYSICIAN ATTEMPTED TO ALTER ITS TIP CONFIGURATION, CAUSING THE INNER WIRE TO PROTRUDE FROM THE COIL. 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 Patient Involvement

  MAUDE report 7896051 ↗
• MalfunctionSep 20, 2018Material Frayed

  IT WAS REPORTED THAT THE SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE WAS FOUND TO BE FRAYED WHILE IT WAS BEING FLUSHED. 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 7895912 ↗
• MalfunctionSep 19, 2018Material Separation; Material Protrusion/Extrusion

  THE COMPLAINANT REPORTED THAT THE SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE WAS USED DURING THE BAV (BALLOON AORTIC VALVULOPLASTY) PROCEDURE. THE PHYSICIAN NOTED AN ISSUE AFTER APPLYING TORQUE AND INSERTING THE DEVICE TIP INSIDE OF THE LEFT VENTRICLE. THE DEVICE WAS REMOVED FROM THE PATIENT, AND IT WAS NOTED THAT THE CORE WIRE PROTRUDED FROM THE OUTER SPRING COIL. ANOTHER DEVICE WITH THE SAME SPECIFICATIONS WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEM. IT WAS FURTHER NOTED THAT THE DISTAL WELD CONNECTION SEPARATED FROM THE COIL AND SAFETY WIRE, BUT THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889897 ↗
• MalfunctionSep 19, 2018Break; Material Separation

  THE COMPLAINANT REPORTED THAT THE CORE WIRE BROKE DURING SHAPING OF THE WIRE TIP WHICH RESULTED IN EXPOSURE AND ELONGATION OF THE SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE. THE DEVICE WAS EXCHANGED WITH ANOTHER DEVICE OF THE SAME SPECIFICATIONS TO CONTINUE THE TAVI (TRANSCATHETER AORTIC VALVE IMPLANTATION) PROCEDURE. IT WAS FURTHER NOTED THAT THE DISTAL WELD CONNECTION SEPARATED FROM THE COIL AND SAFETY WIRE. THIS PRODUCT ISSUE OCCURRED PRIOR TO PATIENT CONTACT, AND IT DID NOT RESULT IN ANY REPORTED IMPACT ON THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7888967 ↗
• MalfunctionSep 17, 2018Material Fragmentation

  IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, WHEN THE PHYSICIAN ATTEMPTED TO ALTER THE CONFIGURATION OF THE AMPLATZ WIRE GUIDE TIP, SOME OF THE COATED MATERIAL WAS REMOVED. ANOTHER DEVICE WAS USED, AND THERE WERE NO ADDITIONAL PROCEDURES REPORTED. IT WAS FURTHER NOTED THAT THE TFE COATING WAS REMOVED NEAR THE DISTAL END OF THE COIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7880946 ↗
• MalfunctionAug 31, 2017Material Deformation; Material Deformation

  A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE WAS USED IN A TRANSCATHETER AORTIC VALVE REPLACEMENT FOR A PATIENT WITH AORTIC VALVULAR STENOSIS. IT WAS REPORTED THAT AFTER THE DEVICE WAS ADVANCED INTO THE PATIENT, THE SHEATH WAS ADVANCED OVER THE WIRE GUIDE (ACCESS SITE UNKNOWN) AND FELT ABNORMAL. THE PHYSICIAN RETRIEVED THE WIRE GUIDE AND OBSERVED THAT THE SPRING COIL OF THE WIRE GUIDE WAS DAMAGED/ELONGATED. ANOTHER WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. 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 6834437 ↗
• MalfunctionJul 12, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE IMPLANTATION(TAVI) USING A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE. THE COMPLAINT WIRE GUIDE WAS ADVANCED THROUGH AN UNSPECIFIED 6FR SHEATH. WHEN THE WIRE GUIDE REACHED THE AORTA, THE PHYSICIAN REPORTED A DIFFERENT/STRANGE FEELING. THE DEVICE WAS THEN RETRIEVED OUT OF THE BODY AND WAS CHECKED REVEALING THE TIP OF THE WIRE GUIDE HAD LOOSENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6707436 ↗