Amplatzer™ Talisman™ 9-PFO-1818Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05415067033307), received between Jun 22, 2022 and Sep 18, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on 25 Aug 2026, an 18-18mm Amplatzer Talisman PFO Occluder was chosen for implant using a 9F Amplatzer Talisman Delivery Sheath to treat patent foramen ovale (PFO). During the procedure, it was noted that occluder conformed to bulbous formation. The deformed device was never released from the delivery cable while inside the patient. There was no angulation or kink noted in the delivery system. Contacts occurred with intracardiac tissue during the occluder deployment. A 25mm Amplatzer PFO Occluder was used as a replacement device to complete the procedure. The patient remained hemodynamically stable throughout the procedure. There was no clinically significant delay in procedure and no adverse patient effects reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819447 ↗
• MalfunctionApr 11, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 17 MAR 2026, A 18-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE THE DEVICE WAS EXPANDING INSIDE THE BODY, IT WAS OBSERVED THE RIGHT ATRIUM DISC OF THE OCCLUDER CONFORMED INTO A BULBOUS DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A 25-18MM AMPLATZER PFO OCCLUDER. 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 24845897 ↗
• MalfunctionFeb 2, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240460 ↗
• MalfunctionOct 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23209403 ↗
• MalfunctionSep 5, 2025Difficult to Fold, Unfold or Collapse; No Apparent Adverse Event; Difficult to Fold, Unfold or Collapse; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR A PATENT FORAMEN OVALE (PFO) WITH A NON-PROMINENT ATRIAL SEPTAL ANEURYSM (ASA) CLOSURE PROCEDURE USING AN 8F AMPLATZER TALISMAN DELIVERY SHEATH. AFTER CORRESPONDING ECHOCARDIOGRAPHIC MEASUREMENTS, THE DEVICE WAS SELECTED. DURING PROCEDURE, THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED AN LAX INTERATRIAL SEPTUM, CHARACTERIZED BY A MARKED, HIGHLY MOBILE BULGING TOWARD THE RIGHT HEART CHAMBER'S AND THE DEVICE EXHIBITS SIGNIFICANT MOBILITY. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THEY DECIDED TO CHANGE THE DEVICE AND A NEW 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN AND IMPLANTED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977191 ↗
• InjuryJun 6, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS IMPLANTED. ON AN UNKNOWN DATE, THE PATIENT HAD A CHECK-UP AND IT WAS NOTICED THAT THE OCCLUDER WAS NO LONGER IN THE HEART. CT SHOWED THAT THE DEVICE WAS IN THE ILIAC ARTERY. ON (B)(6) 2025, THE DEVICE WAS REMOVED VIA PERCUTANEOUS RETRIEVAL TO RESOLVE THE EVENT. THE PHYSICIAN BELIEVES THE CAUSE OF THE EMBOLIZATION WAS DUE TO THE SEPTUM BEING TOO FLOPPY. THE PATIENT WAS LAST REPORTED AS BEING STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159228 ↗
• InjuryApr 3, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 18-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS SELECTED FOR IMPLANT. ECHOCARDIOGRAPHY WAS USED TO SIZE THE DEVICE. DURING PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND ANGIOGRAPHY WERE USED. DURING IMPLANT, STABILITY CHECK WAS PERFORMED AND NO LEAK WAS OBSERVED AROUND THE DEVICE. THE PATIENT DID NOT HAVE A CHANGE IN RHYTHM AND WAS ASYMPTOMATIC. THE OCCLUDER WAS RECAPTURED ONCE PRIOR TO RELEASE. THEN, DEVICE EMBOLIZATION OCCURRED AND THE OCCLUDER EMBOLIZED TOWARDS THE AORTA. THE EMBOLIZED DEVICE DID NOT CAUSE BLOCKAGE. THE USER BELIEVES THE SMALL SIZING CAUSED THE DEVICE EMBOLIZATION. THE OCCLUDER WAS PERCUTANEOUSLY RETRIEVED VIA SNARE AND A NEW 25MM AMPLATZER MULTI-FENESTRATED OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21765235 ↗
• MalfunctionDec 3, 2024Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT ON (B)(6) 2024, AN 18-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT TO CLOSE A PATENT FORAMEN OVALE (PFO) USING AN 8F AMPLATZER TALISMAN DELIVERY SHEATH. DURING DEVICE PREPARATION, IT WAS DIFFICULT TO PULL THE DEVICE INTO THE LOADER. WHEN THE DEVICE WAS DEPLOYED IN THE BODY, THE RIGHT ATRIAL DISC OF THE DEVICE DID NOT EXPAND PROPERLY AND SHOWED A BULBOUS SHAPE. PUSHING WITH THE SHEATH DID NOT HELP. CONTACTS OCCURRED WITH INTRACARDIAC TISSUE DURING THE OCCLUDER DEPLOYMENT. THE DEVICE WAS PULLED BACK INTO THE SHEATH WITH DIFFICULTY, AND THE DEVICE WAS REPLACED WITH ANOTHER 18-18MM AMPLATZER TALISMAN PFO OCCLUDER USING THE SAME DELIVERY SHEATH. THERE WERE NO BENDS OR KINKS BEEN OBSERVED IN THE DELIVERY SHEATH. THE REPLACEMENT DEVICE ENTERED THE LOADER WITHOUT RESISTANCE AND EXPANDED PROPERLY IN THE BODY. AFTER PLACEMENT, THE BUBBLE TEST SHOWED NO RESIDUAL SHUNT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834422 ↗
• InjuryJun 26, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 18-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A UNKNOWN DELIVERY SYSTEM. DURING PROCEDURE, THERE WAS SOME DIFFICULTY DUE TO THE PATIENT BEING SMALL AND THEIR SEPTUM WAS VERY FLOPPY. THE DEVICE WAS POSITIONED IN PATENT FORAMEN OVALE AND TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS USED TO EVALUATE THE POSITION OF THE DEVICE. THE DEVICE WAS RELEASED, BUT THE PATIENT NEEDED MORE PROCEDURES COMPLETED. WHILE COMPLETING THE OTHER PROCEDURES THE DEVICE LOCATION HAD CHANGED AND UPON REVIEW IT WAS SEEN IN LEFT VENTRICLE. THERE WAS PARTIAL OBSTRUCTION/BLOCKAGE OF BLOOD FLOW. DUE TO PATIENT SIZE, TRANSVENOUS RETRIEVAL PROCEDURE WAS NOT AN OPTION AND THE DEVICE WAS SURGICALLY RETRIEVED. THE CAUSE OF EMBOLIZATION WAS UNKNOWN. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19615471 ↗
• MalfunctionOct 28, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 18MM AMPLATZER TALISMAN PFO OCCLUDER WAS SELECTED FOR IMPLANTATION USING A 9F AMPLATZER TALISMAN DELIVERY SHEATH. DURING THE PROCEDURE, THE RIGHT ATRIAL DISK OF THE DEVICE WAS NOTED TO BE DEFORMED . THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO KINK OR BEND NOTED IN THE DELIVERY SYSTEM, AND NO INTERACTION WITH CARDIAC STRUCTURES. IT WAS ATTEMPTED TO RE-SHAPE THE DEVICE, BUT IT WOULD NOT TAKE ITS PROPER SHAPE. THE DEVICE WAS REPLACED WITH ANOTHER 18MM AMPLATZER TALISMAN PFO OCCLUDER, WHICH WAS IMPLANTED SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693742 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A 18-18MM AMPLATZER TALISMAN PATENT FORAMEN OVALE (PFO) OCCLUDER WITH AN UNKNOWN DELIVERY SYSTEM WAS CHOSEN FOR A PFO CLOSURE PROCEDURE ON (B)(6) 2022. DURING PROCEDURE, AFTER THE INITIAL DEPLOYMENT, THE DELIVERY CABLE WAS UNABLE TO BE DETACHED FROM THE TALISMAN PFO OCCLUDER. THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. THE USER LOOSENED THE DEVICE WITH A 1/8 COUNTER-CLOCKWISE TURN AND REINTRODUCED THE DEVICE INTO THE DELIVERY SHEATH. THE DEVICE WAS THEN SUCCESSFULLY DEPLOYED OCCLUDING THE PFO DEFECT. THE DELIVERY SHEATH WAS REMOVED FROM THE PATIENT AND THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WHILE IN RECOVERY. THE PERICARDIAL EFFUSION WAS DRAINED. THE PATIENT REQUIRED ADDITIONAL HOSPITALIZATION DUE TO THE EVENT. THE PATIENT WAS NOTED AS STABLE AND WAS DISCHARGED ON (B)(6) 2022. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 14778898 ↗