AMPLATZER™ 9-ITV05F180/60Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00811806010755), received between Jan 20, 2020 and Apr 7, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Fluid/Blood Leak; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2026, A 5F AMPLATZER TORQVUE DELIVERY SYSTEM WAS CHOSEN FOR A PROCEDURE.PRIOR TO USE, THE DEVICE WAS INSPECTED, AND NO CRACKS WERE NOTED. THE DELIVERY SYSTEM WAS FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE DURING PREPARATION, WITH NO DEVIATIONS REPORTED. DURING IMPLANTATION, THE DELIVERY SYSTEM WAS ADVANCED AND DID COME INTO CONTACT WITH THE PATIENT. WHILE THE DELIVERY SYSTEM WAS BEING POSITIONED THROUGH THE DUCTUS, RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO ADVANCE FROM THE AORTA INTO THE DUCTUS. DURING IMPLANTATION, A LEAK WAS OBSERVED AT THE EXTENSION OF THE HEMOSTATIC KEY, WHICH CONSISTED OF A MIXTURE OF BLOOD AND SOLUTION. NO CRACKS WERE NOTED IN THE DEVICE AT ANY TIME DURING THE PROCEDURE, AND NO ALLEGATIONS WERE REPORTED REGARDING ANY ABBOTT DEVICES USED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24810196 ↗
• InjurySep 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 5-4MM AMPLATZER DUCT OCCLUDER WAS IMPLANTED IN THE PATIENT USING A 5F AMPLATZER TORQVUE DELIVERY SYSTEM. THE OCCLUDER WAS IMPLANTED. A CONTROL ECHOCARDIOGRAM PERFORMED IMMEDIATELY AFTER DEVICE IMPLANTATION IN THE CATHETERIZATION LABORATORY AND IT WAS NOTED THAT THE ANTERIOR VALVE CHORD RUPTURE OF TRICUSPID VALVE. THE RUPTURE OCCURRED WHILE ADVANCING THE DELIVERY SHEATH THROUGH THE TRICUSPID VALVE, MOST LIKELY DUE TO A PATIENT¿SHEATH SIZE MISMATCH, WHICH LED TO THE RUPTURE OF A CHORD OF THE ANTERIOR LEAFLET OF THE TRICUSPID VALVE. THERE WAS NO INTERVENTION REQUIRED. THE PATIENT IS CLINICALLY STABLE, DID NOT REQUIRE MEDICATION DESPITE THE TRICUSPID REGURGITATION, AND WAS DISCHARGED 24 HOURS AFTER THE DUCTUS ARTERIOSUS CLOSURE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 23154864 ↗
• InjurySep 3, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED ON (B)(6) 2024, A 5MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANTATION USING A 4F AMPLATZER TORQVUE DELIVERY CATHETER FOR A 1 MONTH OLD 2 KILOGRAM PATIENT TO TREAT A PATENT DUCTUS ARTERIOSUS (PDA) THAT WAS MEASURED WITH A MINIMUM DIAMETER OF 3.6MM AND A LENGTH OF 6.3MM. DURING IMPLANT THE DEVICE WAS UNSTABLE AND SLIPPED ON THE SIDE OF THE PULMONARY ARTERY. TWO RE-POSITIONS WERE ATTEMPTED WITH NO OPTIMAL RESULTS. THE OCCLUDER AND DELIVERY CATHETER WERE REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 8MM AMPLATZER VASCULAR PLUG II AND 5F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING IMPLANT THE PLUG WAS UNSTABLE. THE PLUG WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW NON-ABBOTT DEVICE USING THE SAME DELIVERY SYSTEM. DURING IMPLANT THE DEVICE WAS UNSTABLE AND SLIPPED INTO THE PULMONARY SIDE. THE DEVICE WAS REMOVED FROM THE PATIENT. AFTER THE DELIVERY SHEATH WAS REMOVED, THE PATIENT PRESENTED WITH A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND 10ML OF FLUID WAS DRAINED. THE USER SUSPECTED THE 5F DELIVERY SYSTEM MAY HAVE BEEN DAMAGED AFTER LOADING THE NON-ABBOTT DEVICE AND CAUSED THE CARDIAC TAMPONADE. THE PATIENT REMAINED IN THE INTENSIVE CA

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 20127171 ↗
• MalfunctionFeb 20, 2024Retraction Problem; Improper or Incorrect Procedure or Method; Difficult to Advance; Positioning Problem; Retraction Problem; Improper or Incorrect Procedure or Method; Difficult to Advance; Positioning Problem

  IT WAS REPORTED THAT ON (B)(6)2024, A 5-4MM AMPLATZER DUCT OCCLUDER I WAS CHOSEN FOR IMPLANTATION UTILIZING A A 5F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PREPARATION, THE DUCT OCCLUDER HAD TROUBLE ADVANCING FROM THE LOADER TO THE SHEATH. AFTER MULTIPLE ATTEMPTS TO PLACE THE DEVICE, IT WAS DECIDED TO RECAPTURE THE OCCLUDER. WHEN ATTEMPTING TO RECAPTURE THE OCCLUDER INTO THE DELIVERY SYSTEM, IT WOULD ONLY RECAPTURE THE WAIST OF THE DEVICE, BUT NOT THE DISC. THE DELIVERY SYSTEM HAD TO BE REMOVED WHILE THE OCCLUDER WAS STILL DEPLOYED AT THE END. A SIGNIFICANT AMOUNT OF TIME WAS ADDED TO THE CASE BUT THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO VESSEL OR TISSUE DAMAGE. THE PATIENT REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739905 ↗
• MalfunctionJul 30, 2020Difficult to Insert; Difficult to Insert

  RELATED MANUFACTURING REFERENCE NUMBER 2135147-2020-00334. ON (B)(6) 2020, A 5F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT#6428039) WAS SELECTED TO IMPLANT A 9-PDA- 003 DEVICE(LOT#597768). DURING THE CANAL DUCT OCCLUSION PROCEDURE, THE DEVICE WAS UNABLE TO BE INTRODUCED IN THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS EXCHANGED FOR ANOTHER 5F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT#7165240) AND THE DEVICE WAS ALSO EXCHANGED FOR ANOTHER 9-PDA-003 DEVICE(LOT#7249390), BUT AGAIN THE 9-PDA-003 DEVICE WAS UNABLE TO BE INTRODUCED INTO THIS DELIVERY SYSTEM. THE PHYSICIAN DECIDED TO EXCHANGE THE DELIVERY SYSTEM AND DEVICE FOR A 6F AMPLATZER TORQVUE DELIVERY SYSTEM(LOT#7237301) AND A 9 PDA-004 DEVICE(LOT#6914380), BUT THE PATIENT'S ANATOMY WAS TOO SMALL FOR THIS DELIVERY SYSTEM. THE PHYSICIAN DECIDED TO CLOSE THE PATENT DUCTUS ARTERIOSUS WITH A COIL (COOK IM WCE 3 PDA5). THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, BUT THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS CURRENTLY STABLE AND DISCHARGED. THE PHYSICIAN BELIEVED THAT THE FIRST TWO SHEATHS USED IN THE PROCEDURE WERE TOO SMALL FOR THE DEVICES. LATER, ANOTHER PHYSICIAN WAS ABLE TO FIT THE DEVICE ONTO THE S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347474 ↗
• MalfunctionJul 30, 2020Difficult to Insert; Difficult to Insert

  RELATED MANUFACTURING REFERENCE NUMBER 2135147-2020-00335. ON (B)(6) 2020, A 5F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT#6428039) WAS SELECTED TO IMPLANT A 9-PDA- 003 DEVICE(LOT#597768). DURING THE CANAL DUCT OCCLUSION PROCEDURE, THE DEVICE WAS UNABLE TO BE INTRODUCED IN THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS EXCHANGED FOR ANOTHER 5F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT#7165240) AND THE DEVICE WAS ALSO EXCHANGED FOR ANOTHER 9-PDA-003 DEVICE(LOT#7249390), BUT AGAIN THE 9-PDA-003 DEVICE WAS UNABLE TO BE INTRODUCED INTO THIS DELIVERY SYSTEM. THE PHYSICIAN DECIDED TO EXCHANGE THE DELIVERY SYSTEM AND DEVICE FOR A 6F AMPLATZER TORQVUE DELIVERY SYSTEM(LOT#7237301) AND A 9 PDA-004 DEVICE(LOT#6914380), BUT THE PATIENT'S ANATOMY WAS TOO SMALL FOR THIS DELIVERY SYSTEM. THE PHYSICIAN DECIDED TO CLOSE THE PATENT DUCTUS ARTERIOSUS WITH A COIL (COOK IM WCE 3 PDA5). THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, BUT THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS CURRENTLY STABLE AND DISCHARGED. THE PHYSICIAN BELIEVED THAT THE FIRST TWO SHEATHS USED IN THE PROCEDURE WERE TOO SMALL FOR THE DEVICES. LATER, ANOTHER PHYSICIAN WAS ABLE TO FIT THE DEVICE ONTO THE S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347467 ↗
• InjuryJul 15, 2020Difficult to Insert; Difficult to Insert

  ON (B)(6) 2020, A 5/4 AMPLATZER DUCT OCCLUDER I WAS SELECTED FOR IMPLANT USING 5 FRENCH DELIVERY SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT ADVANCE THE DEVICE INTO THE HUB OF THE SHEATH. AFTER MULTIPLE ATTEMPTS, A NEW 6 FRENCH DELIVERY SYSTEM WAS SELECTED TO SUCCESSFULLY DEPLOY THE DEVICE. THE PHYSICIAN REPORTED A SIGNIFICANT DELAY IN THE PROCEDURE LEADING TO AN INCREASED AMOUNT OF BLOOD LOSS. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10277499 ↗
• MalfunctionMar 26, 2020Difficult to Insert; Improper or Incorrect Procedure or Method; Difficult to Insert; Improper or Incorrect Procedure or Method

  IT WAS NOT POSSIBLE TO ADVANCE A ADO SIZE 3, FROM THE LOADER TO THE APROPRIATE 5F DS. EVERYTHING HAD TO BE CHANGED TO A 6F DS. THE 6F DS WAS TO BIG TO CROSS THE PDA (VERY NARROW AT THE PULMONARY ARTERY SIZE) THE ADO (MOUNTED IN THE CABLE) WAS BACK LOADED IN THE INITIAL 5F DS TO TEST THE DS INNER DIAMETER. IT WAS POSSIBLE TO PULL IN THE DEVICE AND TO PULL IT OUTFROM THE DS HUB THE CARDIOLOGIST CONCLUDED THE PROBLEM WAS THE CONNECTION BETWEEN THE LOADER AND THE DS. THE LOADER SCREW WAS CUT OUT. THE 5F DS WAS AGAIN INSERTED IN THE PATIENT. THE CARDIOLOGIST DID A "DIRECT CONNECTION" OF THE CUT LOADER WITH THE DS, AND ADVANCED. THE ADO INTO THE DS UNDER CONSTANT MANUAL SALINE FLUSH TO AVOID AR COMING IN. THE ADO WAS CORRECTLY IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9882861 ↗
• MalfunctionJan 20, 2020Difficult to Insert; Failure to Advance; Difficult to Insert; Failure to Advance

  ON (B)(6) 2019, A 5/4 MM PDA OCCLUDER WAS SELECTED FOR IMPLANT USING A TORQVUE DELIVERY SYSTEM 5FR 90/080. DURING THE PROCEDURE, THE OCCLUDER FAILED TO ADVANCE INTO THE DELIVERY SHEATH. THE PHYSICIAN ATTEMPTED TO RETRACT THE DEVICE, BUT IT REMAINED STUCK IN THE LOADING SYSTEM. A NEW 5/4MM PDA OCCLUDER AND TORQVUE 5FR 90/080 WERE SELECTED. UPON ADVANCEMENT, THE OCCLUDER WAS STUCK IN THE SHEATH AGAIN, BUT THIS TIME IT WAS SUCCESSFULLY RETRIEVED INTO THE LOADING SYSTEM. A THIRD DELIVERY SYSTEM TORQVUE 6FR WAS SELECTED AND SUCCESSFULLY USED TO IMPLANT THE SECOND PDA OCCLUDER. THE PATIENT IS REPORTED TO BE STABLE. MANUFACTURER REPORT NUMBER: 2135147-2020-00019, 2182269-2020-00001, 2135147-2020-00005.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9606768 ↗