Amplatzer™ 9-GW-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00811806010724), received between May 7, 2022 and Aug 13, 2026 — classified as 2 deaths, 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240553 ↗
• MalfunctionSep 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, AN AMPLATZER GUIDEWIRE WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, WHEN THE WIRE WAS BEING REMOVED AT THE SAME TIME OF POSITIONING THE IMPLANT, IT WAS NOTED THAT THE GUIDE WIRE WAS BROKEN. THE DEVICE WAS SUCCESSFULLY IMPLANTED AND ALL PARTS OF THE WIRE WERE REMOVED WITH THE DELIVERY SYSTEM. THERE WAS NO INJURIES RELATED TO THE BROKEN WIRE. THERE WAS A 5MIN DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008207 ↗
• MalfunctionJan 3, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT AN AMPLATZER GUIDEWIRE WAS SELECTED FOR A PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE WHILE REMOVING THE GUIDEWIRE FROM THE 18MM AMPLATZER SIZING BALLOON II, IT WAS BELIEVED THAT A BLOOD CLOT WAS NOTED ATTACHED TO THE WIRE ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THERE WAS SOME DIFFICULTY REMOVING THE GUIDEWIRE FROM THE BALLOON. UPON SEPARATION IT WAS NOTED THAT THERE WAS NO CLOT BUT THE GUIDEWIRE WAS OBSERVED TO HAVE A STRAND OF WIRE STICKING OUT FROM THE SIDE. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21071233 ↗
• MalfunctionDec 26, 2024Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, AN AMPLATZER GUIDEWIRE WAS USED DURING A PATENT FORAMEN OVALE (PFO) PROCEDURE. DURING THE PROCEDURE, THE GUIDEWIRE WAS ATTEMPTED TO BE REMOVED FROM THE 6F CATHETER, BUT IT WOULD NOT SLIDE OUT. THE END OF THE WIRE HAD FRAYED, SO THE WIRE UNABLE TO BE REMOVED WITHOUT REMOVING ALL THE WIRES AND CATHETERS. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT, THE WIRE WAS UNABLE TO BE REMOVED FROM THE CATHETER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21022061 ↗
• MalfunctionNov 27, 2024Fracture; Difficult to Advance; Fracture; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2024, AN AMPLATZER GUIDEWIRE WAS CHOSEN FOR PROCEDURE. THERE WERE NO ISSUES WITH THE PRODUCT PACKAGING. THERE WERE NO PROBLEMS NOTED DURING DEVICE PREPARATION. DURING THE PROCEDURE, THERE WAS UNUSUAL RESISTANCE WHEN TRYING TO PASS THE WIRE THROUGH THE INTRODUCER. THE DECISION WAS MADE TO PROCEED WITH USING THE WIRE. UPON INTRODUCING THE 18MM AMPLATZER SIZING BALLOON II, RESISTANCE WAS FELT WHEN ADVANCING THE BALLOON, AND THE WIRE BEGAN TO SHOW SIGNS OF ENTANGLEMENT. WHEN THE BALLOON WAS ABOUT TO BE REMOVED, THE SITUATION WORSENED, AND THE WIRE STARTED TO TANGLE AND SHOW SIGNS OF WEAR WITH THE NYLON FRAYING AND FORMING A BUNDLE OF FIBERS. THE WIRE WAS REMOVED AND REPLACED WITH ANOTHER AMPLATZER GUIDEWIRE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796183 ↗
• InjuryMay 31, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN TO CLOSE A VENTRICULAR SEPTAL DEFECT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. HEPARIN WAS ADMINISTERED, AND THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 230 SECONDS. CLOSURE OF THE DEFECT WAS PERFORMED WITHOUT DIFFICULTY IMPLANTING THE DEVICE. ON ECHOCARDIOGRAPHIC REVIEW, A PERICARDIAL EFFUSION WAS EVIDENT. A PERFORATION OF THE RIGHT VENTRICLE IN THE ANTERIOR AREA WAS NOTED. PERICARDIOCENTESIS WAS REQUIRED FOR THE PERICARDIAL EFFUSION, AND 160CC WERE DRAINED. OPEN HEART SURGERY WAS REQUIRED TO REPAIR THE PERFORATION. THE PHYSICIAN BELIEVED THAT THE PERICARDIAL EFFUSION WAS POSSIBLY CAUSED BY THE NON-ABBOTT CATHETER OR ABBOTT GUIDEWIRE USED TO ACCESS THE RIGHT VENTRICLE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 19441088 ↗
• MalfunctionFeb 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2024, AN AMPLATZER GUIDEWIRE (9-GW-002) WAS CHOSEN FOR THE PROCEDURE. AFTER REMOVING THE GUIDEWIRE AFTER IMPLANTING THE OCCLUDER, A FRACTURE WAS NOTED AT THE DISTAL END OF THE GUIDEWIRE (CLOSE TO THE J-TIP) WITH EXPOSED TIPS. THERE WAS NO EXCESSIVE MANIPULATION OF THE GUIDEWIRE DURING USE. THE GUIDEWIRE WAS PLACED IN THE LEFT SUPERIOR PULMONARY VEIN WITHOUT ANY DIFFICULTY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18714647 ↗
• MalfunctionFeb 9, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 08F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS CHOSEN FOR THE PROCEDURE. DURING ADVANCEMENT OF THE OCCLUDER THROUGH THE DELIVERY SYSTEM, GREAT RESISTANCE WAS MET INSIDE THE DELIVERY SYSTEM, AS IF SOMETHING WAS BLOCKING THE PASSAGE OF THE PROSTHESIS. A REPLACEMENT 08F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. IN ADDITION TO THIS INCIDENT WITH THE DELIVERY SYSTEM, IT WAS INDICATED THAT THE PHYSICIAN FELT GREAT ROUGHNESS IN THE MATERIAL OF THE AMPLATZER GUIDEWIRE USED. PORTIONS OF SMALL WRINKLES WERE OBSERVED ON THE GUIDEWIRE AFTER REMOVAL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18678334 ↗
• MalfunctionFeb 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6)2024, AN AMPLATZER GUIDEWIRE WAS CHOSEN FOR THE PROCEDURE. DURING DEVICE PREPARATION, PRIOR TO INTRODUCTION INTO THE PATIENT, IT WAS INDICATED THAT THE PHYSICIAN EXPERIENCED GREAT ROUGHNESS IN THE MATERIAL. SMALL WRINKLES (GRIPPING) ON THE GUIDEWIRE WERE OBSERVED. THE DEVICE WAS USED WITH NO FURTHER COMPLICATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18671633 ↗
• MalfunctionJul 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2023, AN AMPLATZER GUIDEWIRE WAS CHOSEN FOR USE DURING PROCEDURE. THE GUIDEWIRE WAS INSPECTED PRIOR TO PROCEDURE AND WAS FLUSHED IN LOOP PRIOR TO ADVANCING, AND IT WAS BARELY NOTED THAT THE DISTAL PART OF THE GUIDEWIRE APPEARED TO HAVE PARTIAL UNEVEN COATING. ONCE THE GUIDEWIRE WAS PLACED, THE BALLOON WAS ADVANCED. DURING ADVANCING OF THE BALLOON, PART OF THE GUIDEWIRE CAUSED A DISSECTION OF THE BALLOON. THE DEVICE WAS REPLACED WITH A NON-ABBOTT GUIDEWIRE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336830 ↗
• MalfunctionJun 9, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Material Twisted/Bent; Difficult to Remove; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, A 14F AMPLATZER AMULET DELIVERY SHEATH WAS CHOSEN FOR PROCEDURE. A 0.035 INCH AMPLATZER GUIDEWIRE WAS USED TO EASE THE INSERTION OF THE DELIVERY SHEATH WITHIN THE LEFT ATRIUM AND THE LEFT UPPER PULMONARY VEIN. ONCE THE DELIVERY SHEATH WAS IN PLACE IN THE LEFT UPPER PULMONARY VEIN, THE DILATOR AND GUIDEWIRE WERE WITHDRAWN TOGETHER FROM THE DELIVERY SHEATH. ONCE ON THE TABLE, THE GUIDEWIRE COULD NOT BE REMOVED FROM THE DILATOR AFTER TWO ATTEMPTS WITHOUT SUCCESS. THERE APPEARED TO BE A KINK IN THE DISTAL TIP OF THE GUIDEWIRE, WHICH WAS WHY THE GUIDEWIRE COULD NOT BE REMOVED FROM THE DILATOR. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101070 ↗
• MalfunctionApr 11, 2023Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, A 1.5 MM MODIFIED J-TIPFIXED BODY AMPLATZER GUIDEWIRE WAS CHOSEN FOR A MITRACLIP IMPLANT PROCEDURE. IT WAS REPORTED THE TRANSSEPTAL PUNCTURE WAS PERFORMED IN THE INTERATRIAL SEPTUM WITHOUT COMPLICATION. THE 1.5MM GUIDEWIRE WAS PLACED IN THE LEFT SUPERIOR PULMONARY VEIN AND THE MITRACLIP G4 STEERABLE GUIDE CATHETER WAS ADVANCED PER INSTRUCTIONS FOR USE (IFU). WHEN THE DILATOR WAS RETRACTED AND THE 1.5MM GUIDEWIRE WAS TO BE PLACED INSIDE TO MAKE THE EXCHANGE WITH THE MITRACLIP G4 CLIP DELIVERY SYSTEM, IT WAS NOTED THERE WAS A KINK OBSERVED AT THE TIP OF THE GUIDEWIRE. IT WAS REPORTED WHEN THE PHYSICIANS PULLED ON THE GUIDEWIRE, THEY EXPERIENCED DIFFICULTY IN MOVING, TURNING, OR RETRACTING THE GUIDEWIRE. IT WAS THEN REPORTED A NON-ABBOTT GUIDE LINER WAS INSERTED TO PROVIDE EXTRA SUPPORT, INJECTED CONTRAST, AND THE GUIDEWIRE WAS RETRACTED BY PULLING WITH FORCE. A SECOND CONTRAST INJECTION CONFIRMED THERE WAS NO DAMAGE TO THE PATIENT AND NO NEED FOR FURTHER TREATMENT. THE REST OF THE PROCEDURE WAS PERFORMED WITHOUT FURTHER COMPLICATIONS AND THERE WAS NO REPORT OF ANY CLINICAL SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714602 ↗
• DeathFeb 6, 2023Difficult to Remove; Use of Device Problem; Patient Device Interaction Problem; Difficult to Remove; Use of Device Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, AN UNKNOWN MITRACLIP WAS CHOSEN FOR IMPLANT USING AN AMPLATZER GUIDEWIRE. DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE SUPER STIFF GUIDEWIRE, WHICH WAS ANCHORED IN THE LEFT SUPERIOR PULMONARY VEIN. AFTER A FEW ATTEMPTS, THE GUIDEWIRE WAS REMOVED INTO THE MITRACLIP STEERABLE GUIDE CATHETER. MINUTES LATER, THE PATIENT PRESENTED SIGNIFICANT BLEEDING THROUGH THE OROTRACHEAL TUBE WITH A DROP IN OXYGEN SATURATION. THE REVERSAL OF HEPARIN WITH PROTAMINE WAS PERFORMED, AND THE OROTRACHEAL TUBE WAS CHANGED TWICE, AS IT WAS OBSTRUCTED BY CLOTS. THE BLEEDING GRADUALLY STABILIZED, AND THE PATIENT REGAINED OXYGEN SATURATION. THE MITRACLIP PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED AS STABLE AND ON MECHANICAL VENTILATION IN THE INTENSIVE CARE UNIT. ON AN UNKNOWN DATE, THE PATIENT DIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypoxia; Perforation of Vessels

  MAUDE report 16303340 ↗
• DeathMay 7, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT UNDERWENT AN IMPLANT OF A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. DURING THE PROCEDURE A THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE OCCLUDER WAS PERFORMING AS INTENDED. THE NIGHT OF (B)(6) 2022, THE PATIENT DEVELOPED ISSUES WITH THEIR BLOOD PRESSURE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED THAT THE PATIENT HAD A PERICARDIAL EFFUSION LEADING TO TAMPONADE. A PERICARDIOCENTESIS WAS IMMEDIATELY PERFORMED BUT THE BLEEDING WAS UNCONTROLLED. THE PATIENT WAS SENT TO OPEN HEART SURGERY AT A DIFFERENT HOSPITAL. DURING THE SURGERY, A HOLE WAS FOUND IN THE LAA. AFTER THE SURGICAL PROCEDURE, THE PATIENT WAS CLOSELY OBSERVED. TWO DAYS POST SURGICAL PROCEDURE, THE PATIENT PASSED AWAY DUE TO MULTI-ORGAN SYSTEM FAILURE. IT WAS THOUGHT THAT THE LAA WAS PERFORATED USING THE AMPLATZER GUIDEWIRE PRIOR TO THE OCCLUDER PLACEMENT. THERE ARE NO ALLEGATIONS AGAINST THE 20MM AMPLATZER AMULET OCCLUDER.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 14313821 ↗