Amplatzer™ Talisman™ 9-PFO-2518Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 05415067033314), received between May 16, 2022 and Sep 29, 2026 — classified as 42 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (76 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 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Separation Problem; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941051 ↗
• MalfunctionAug 7, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 25-18mm Amplatzer Talisman PFO Occluder was implanted for a patent foramen ovale (PFO) closure procedure. On (b)(6)2026, an echocardiography performed and noted that the device appearing to be located in the right atrium on the atrial side, but seemed actually entrapped in the aortic¿tricuspid trigone.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176851 ↗
• MalfunctionApr 21, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING, IT WAS DISCOVERED THAT THE RIGHT ATRIAL DISC CONFORMED INTO A "PUFFY" DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 25-18MM AMPLATZER TALISMAN 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 24934254 ↗
• MalfunctionMar 30, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT (B)(6) 2026. A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE THE PLACEMENT OF THE DEVICE IT WAS DISCOVERED THAT THE RIGHT DISCS OF THE OCCLUDER TOOK FORM OF 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 NEW 25-18MM AMPLATZER TALISMAN 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 24718819 ↗
• MalfunctionMar 25, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24683942 ↗
• MalfunctionMar 23, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026 A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE AND WAS NOTED TO BE BULKING LIKE A BULBOUS DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 25-18MM AMPLATZER TALISMAN 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 24668725 ↗
• MalfunctionMar 23, 2026Premature Separation

  IT WAS REPORTED ON (B)(6) 2026, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. AFTER DEPLOYMENT OF THE OCCLUDER, THE PHYSICIAN PERFORMED A STANDARD WIGGLE TEST TO CONFIRM STABILITY. WHILE ATTEMPTING TO DETACH THE DELIVERY CABLE FROM THE IMPLANTED DEVICE, THE OCCLUDER WAS INADVERTENTLY PULLED BACK THROUGH THE PFO, AND THE RIGHT ATRIAL DISC BECAME PARTIALLY CAPTURED WITHIN THE DELIVERY SHEATH WHILE THE DELIVERY CABLE DETACHED. THE SHEATH, CONTAINING APPROXIMATELY HALF OF THE OCCLUDER, WAS ADVANCED DOWN TO THE FEMORAL VEIN, WHERE THE PHYSICIAN RE-ATTACHED THE OCCLUDER TO THE DELIVERY CABLE, FULLY RECAPTURED THE DEVICE INTO THE SHEATH, AND SUBSEQUENTLY REMOVED THE SYSTEM FROM THE BODY. IT WAS CONFIRMED THAT THE SEPARATION WAS NOTED IN THE END WHEN THE PHYSICIAN WANTED TO RELEASE THE OCCLUDER. THE PROCEDURE WAS THEN COMPLETED USING A NEW 30-25MM AMPLATZER TALISMAN PFO OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE ALIVE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24666546 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (b)(6) 2026, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO SHEATH DURING A PFO CASE. A MINOR PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE START OF THE PROCEDURE. THE PATIENT WAS IN SINUS RHYTHM, AND HEPARIN WAS ADMINISTERED WITH ACTIVATED CLOTTING TIME REPORTED TO BE GREATER THAN 250 SECONDS. THE PHYSICIAN CROSSED THE SEPTUM WITH A J-WIRE FOLLOWED BY A MULTIPURPOSE CATHETER, WHICH WAS THEN EXCHANGED FOR A STIFF NON-ABBOTT EXCHANGE WIRE POSITIONED IN THE UPPER PULMONARY VEIN, WITH NO MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES REPORTED. THE 9F TREVISIO SHEATH WAS ADVANCED ACROSS THE SEPTUM INTO THE LEFT ATRIUM, AND A 25¿MM TALISMAN PFO DEVICE WAS PREPARED AND ADVANCED THROUGH THE SHEATH. DEPLOYMENT OF THE LEFT ATRIAL DISC WAS INITIATED; HOWEVER, VISUALIZATION OF THE DISC IN THE LEFT ATRIUM ON TEE WAS DIFFICULT. SHORTLY THEREAFTER, THE PATIENT¿S BLOOD PRESSURE DECREASED FROM 120/60 TO 65/45. A TEE ASSESSMENT REVEALED A CIRCUMFERENTIAL PERICARDIAL EFFUSION, AND THE PHYSICIAN CONCLUDED THAT CARDIAC TAMPONADE WAS PRESENT. PERICARDIOCENTESIS WAS PERFORMED, DURING WHICH APPROXIMATELY ONE LITER OF FLUID WAS REMOVED, RES

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24652023 ↗
• MalfunctionFeb 27, 2026Difficult to Fold, Unfold or Collapse; Product Quality Problem; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE TEAM DETERMINED THAT THE 25 MM OCCLUDER APPEARED TO BE UNDERSIZED, AND UPON REMOVAL OF THE OCCLUDER FROM THE CATHETER, THE LEFT ATRIAL DISC WAS OBSERVED TO BE MALFORMED, WITH THE POLYESTER FABRIC NOT APPEARING TO BE UNIFORMLY SEWN WITHIN THE DISC. ALTHOUGH IT INITIALLY APPEARED THAT THE NITINOL LEFT ATRIAL DISC ITSELF WAS DEFORMED, CLOSER INSPECTION INDICATED THAT THE POLYESTER FABRIC WITHIN THE DISC DID NOT FULLY COVER THE ENTIRE DISC, REPRESENTING AN IRREGULAR SEWING PATTERN. NO PROTRUDING THREADS WERE IDENTIFIED, AND THE DEVICE HAD BEEN THOROUGHLY INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED BEFOREHAND. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A NEW 30-25 MM AMPLATZER TALISMAN PFO OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, WITH NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475421 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM TO A PATIENT. DURING THE PROCEDURE, AFTER IMPLANTATION, IT WAS OBSERVED THAT THE PATIENT DEVELOPED RIGHT BUNDLE BRANCH BLOCK (RBBB). IT WAS ALSO REPORTED THAT THE PHYSICIAN DIDN'T MENTION THAT THE DEVICE WAS THE CAUSE AND THE PATIENT IS NOTED TO BE STABLE.

  Patient problems: Heart Block

  MAUDE report 24475416 ↗
• MalfunctionFeb 24, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25-18 MM AMPLATZER TALISMAN PFO OCCLUDER WAS IMPLANTED USING AN NON- ABBOTT DELIVERY SYSTEM. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WAS USED AS THE IMAGING MODALITY DURING THE PROCEDURE, AND DEVICE SIZING WAS DETERMINED AT THE DISCRETION OF THE IMPLANTER. FOLLOWING DEVICE DEPLOYMENT, IT WAS REPORTED THAT THE DEVICE APPEARED STABLE, AND A STABILITY CHECK WAS PERFORMED USING THE ¿PUSH¿PULL¿ METHOD. THE IMPLANTER REPORTED THAT NO PERI-DEVICE LEAK WAS DETECTED AND THAT THE PATIENT DID NOT EXPERIENCE ANY RHYTHM CHANGES OR CLINICAL SIGNS OR SYMPTOMS DURING OR IMMEDIATELY FOLLOWING THE PROCEDURE. ON (B)(6)2026, IT WAS DISCOVERED THAT THE IMPLANTED OCCLUDER HAD COMPLETELY DISLODGED FROM THE INTENDED IMPLANT SITE AND WAS FOUND TO BE EMBOLIZED IN THE ABDOMINAL AORTA, WHICH WAS IDENTIFIED THROUGH BOTH ECHOCARDIOGRAPHY AND COMPUTED TOMOGRAPHY (CT) IMAGING STUDIES. THE IMPLANTER REMAINED UNSURE OF THE CAUSE OF EMBOLIZATION, NOTING THAT THE DEVICE HAD INITIALLY APPEARED STABLE AFTER DEPLOYMENT. A PERCUTANEOUS RETRIEVAL VIA THE GROIN WAS PERFORMED ON 06 MARCH 2026, AND THE RETRIEVAL WAS NOT CONSIDERED AN EMERGENCY PROCEDURE. THE DEVICE WAS SUCCESSFULLY RETRIEVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434476 ↗
• InjuryFeb 19, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS IMPLANTED. THE PROCEDURE WAS PERFORMED UNDER INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND FLUOROSCOPIC GUIDANCE. AFTER DEVICE DEPLOYMENT AND PERFORMANCE OF A STABILITY CHECK (CONFIRMED AS PERFORMED), IT WAS OBSERVED THROUGH INTRACARDIAC ECHO AND FLUOROSCOPY THAT THE OCCLUDER HAD SHIFTED IN POSITION WITHIN THE INTENDED IMPLANT SITE. SPECIFICALLY, THE RIGHT SUPERIOR DISK SLIPPED OFF THE PFO LIMBUS AND INTO THE PFO TUNNEL, INDICATING MIGRATION. THE IMPLANTER BELIEVED THE CAUSE OF THE MIGRATION WAS THAT THE 25-18MM DEVICE WAS TOO SMALL FOR THE PFO. THE MIGRATED OCCLUDER WAS SUBSEQUENTLY REMOVED FROM THE PATIENT¿S BODY USING A SNARE WITHOUT ANY ISSUE. THROUGHOUT THIS PERIOD, NO LEAK WAS DETECTED AROUND THE DEVICE, AND NO RHYTHM CHANGES OR CLINICAL SIGNS OR SYMPTOMS SUCH AS ARRHYTHMIA, INTERACTION WITH A VALVE, OR HEMODYNAMIC INSTABILITY WERE OBSERVED. THE DEVICE MIGRATION WAS IDENTIFIED BASED ON IMAGING FINDINGS SHORTLY AFTER DEPLOYMENT. THERE WERE NO DIFFICULTIES WITH DEVICE IMPLANTATION, INCLUDING NO NEED FOR MULTIPLE RECAPTURES OR REPOSITIONING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE IMPLANTATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390246 ↗
• InjuryFeb 6, 2026Patient-Device Incompatibility

  N/A.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24283861 ↗
• InjuryJan 23, 2026Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TALISMAN DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS OPENED AND PREPARED IN A STERILE MANNER, ENSURING ALL AIR WAS REMOVED FROM THE SHEATH AND DILATOR. THE OCCLUDER DEVICE WAS PREPARED UNDER WATER BY THE PHYSICIAN WHILE THE SCRUB TECHNICIAN FLUSHED NORMAL SALINE THROUGH THE SIDE PORT OF THE TOUEY. DURING THE INITIAL PREPARATION, A BUBBLE WAS NOTED AT THE PROXIMAL END OF THE DEVICE, PROMPTING THE PHYSICIAN TO REMOVE AND RELOAD THE DEVICE, AFTER WHICH NO AIR WAS OBSERVED. A NON-ABBOTT GUIDEWIRE WAS THEN PLACED THROUGH THE MULTI-PURPOSE (MP) CATHETER POSITIONED ACROSS THE PFO, FOLLOWED BY REMOVAL OF THE MP CATHETER AND SHEATH. THE 8F AMPLATZER TALISMAN DELIVERY SYSTEM WAS ADVANCED ACROSS THE 30-25MM AMPLATZER TALISMAN PFO OCCLUDER AND POSITIONED AT THE OSTIUM OF THE LEFT UPPER PULMONARY VEIN, AND A WET-TO-WET CONNECTION WAS ESTABLISHED WITH THE DEVICE LOADER. THE DEVICE WAS ADVANCED WITHOUT FLUOROSCOPY UNTIL THE DEMARCATION LINE REACHED THE TOUEY, AND UNDER FLUOROSCOPIC AND ICE GUIDANCE, THE LEFT ATRIAL DISC WAS DEPLOYED WITHOUT VISIBLE AIR. AT THE TIME OF DEPLOYMEN

  Patient problems: Air Embolism; Bradycardia; Myocardial Infarction; Non specific EKG/ECG Changes

  MAUDE report 24169050 ↗
• MalfunctionJan 16, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101600 ↗
• MalfunctionJan 16, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SHEATH IN A CASE INVOLVING A LONG TUNNEL OF 10 MM OR LESS. THE DEVICE WAS DEPLOYED IN THE PFO; HOWEVER, THE LEFT ATRIAL (LA) AND RIGHT ATRIAL (RA) DISCS APPEARED EXCESSIVELY OPEN AND SEPARATED. ATTEMPTS TO CORRECT THE POSITIONING BY PRESSING THE DEVICE WITH THE SHEATH DID NOT RESULT IN IMPROVEMENT, AND THE RA DISC WAS NOTED TO APPEAR TWISTED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A NEW 25-18 MM AMPLATZER TALISMAN PFO OCCLUDER. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. 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 24101599 ↗
• InjuryDec 23, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN TO IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SYSTEM. PFO CLOSURE WAS ATTEMPTED WITH THE 25 MM TALISMAN DEVICE UNDER FLUOROSCOPIC GUIDANCE. FOLLOWING THE FINAL CONTRAST INJECTION, AN ABNORMALITY IN THE DEVICE POSITION AND SHAPE WAS OBSERVED. AN ICE GUIDING CATHETER WAS UTILIZED TO FURTHER ASSESS DEVICE PLACEMENT. ICE IMAGING CONFIRMED THAT THE DEVICE WAS DEPLOYED WITHIN THE PFO TUNNEL AND WAS NOT ADEQUATELY COVERING BOTH SIDES OF THE SEPTUM. THE IMAGES ALSO INDICATED A LONG PFO TUNNEL MEASURING GREATER THAN 20 MM. THE DEVICE WAS SNARED AND RETRIEVED. IT WAS NOTED THAT THE DEVICE WAS NOT POSITIONED PROPERLY DUE TO THE DEVICE WAS MIS-SIZED. THE MIS-SIZED WAS DETERMINED WHEN RETRIEVING THE FIRST DEVICE. THE TUNNEL LENGTH WAS THEN SUSPECTED TO BE LONGER THAN EXPECTED. AFTER THE DEVICE WAS COMPLETELY RETRIEVED, THE TUNNEL WAS MEASURED ON ICE AND MEASURED 20MM. THEY CONCLUDED THAT THE 25MM PFO DEVICE WAS TOO SMALL. SUBSEQUENTLY, THE PFO WAS CLOSED USING A 35 MM AMPLATZER TALISMAN DEVICE. THE REPLACEMENT DEVICE WAS IMPLANTED SUCCESSFULLY AND REMAINED IMPLANTED. NO LEAK WAS OBSERVED IN THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881893 ↗
• MalfunctionDec 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825013 ↗
• InjuryDec 10, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25¿18 MM AMPLATZER PATENT FORAMEN OVALE (PFO) OCCLUDER WAS IMPLANTED IN THE PATIENT. THE SIZING OF THE DEVICE WAS DETERMINED USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TOE). DURING THE PROCEDURE, FLUOROSCOPY WAS USED AS THE IMAGING MODALITY. ON (B)(6) 2025, THE PATIENT RETURNED FOR A FOLLOW-UP VISIT FOUR WEEKS AFTER THE IMPLANTATION. DURING THE CHECK-UP, A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TOE) IMAGING STUDY IDENTIFIED THAT THE OCCLUDER HAD EMBOLIZED TO THE DESCENDING AORTA. THE CLINIC DECIDED TO ATTEMPT RETRIEVAL OF THE OCCLUDER VIA AN INTERVENTIONAL SNARING PROCEDURE. AFTER SEVERAL HOURS, THE DEVICE COULD NOT BE REMOVED. THE LOCALIZATION WAS THEN CHANGED FROM THE DESCENDING AORTA TO THE INTERNAL ILIAC ARTERY, WHERE A VASCULAR SURGEON WAS ABLE TO EXPLANT THE DEVICE. THE PATIENT WAS REPORTED TO BE STABLE AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE IMPLANTER BELIEVES THE CAUSE OF EMBOLIZATION WAS MISJUDGMENT OF THE ANATOMY. A STABILITY CHECK WAS PERFORMED DURING IMPLANTATION, AND THE WIGGLE MANOEUVRE WAS USED. THERE WAS NO DIFFICULTY DURING IMPLANTATION, AND NO MULTIPLE RECAPTURES OR REPOSITIONING WERE REQUIRED. THE PATIENT EXHIBITED NO CLI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772002 ↗
• MalfunctionDec 5, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, WHEN THE DEVICE WAS EXPLANDING INSIDE THE BODY, IT WAS OBSERVED THAT THE RIGHT ATRIAL (RA) DISC OF THE OCCLUDER DEFORMED INTO BULBOUS SHAPE ALONG WITH CORE MISALIGNMENT. 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 NEW 25-18MM AMPLATZER TALISMAN 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 23729885 ↗
• MalfunctionNov 18, 2025Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25- 18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER WAS DEPLOYED WITH A BULBOUS APPEARANCE OF THE RIGHT DISC. THIS DEFORMATION DID NOT RESOLVE PRIOR TO RELEASE. THE DEVICE WAS NOT RECAPTURED ONCE IT WAS DEPLOYED. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PHYSICIAN WILL MONITOR THE PATIENT FOR ANY POTENTIAL COMPLICATIONS. HE 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 23584366 ↗
• MalfunctionNov 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, THE RIGHT ATRIAL DISC WAS BULGED AFTER DEPLOYMENT. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 25-18MM AMPLATZER TALISMAN 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 23571165 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, A 25- 18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN AS AN IMPLANT USING A 8F AMPLATZER TALISMAN DELIVERY SYSTEM FOR A PERCUTANEOUS TRANSCATHETER CLOSURE OF A PATENT FORAMEN OVALE (PFO). DURING DEPLOYMENT OF THE LEFT ATRIAL DISC, ST SEGMENT ELEVATION WAS OBSERVED ON ELECTROCARDIOGRAM. THE CHANGES WERE ATTRIBUTED TO THE PRESENCE OF AIR AFFECTING THE RIGHT CORONARY ARTERY (RCA). AIR WAS NOTED IN THE PATIENT DURING PFO IMPLANT. THE PHYSICIAN BELIEVES THIS WAS DUE TO AIR IN THE TALISMAN SHEATH OR TALISMAN PFO OCCLUDER SYSTEM AND RELEASED WHEN THE PFO OCCLUDER DISC WAS DEPLOYED. NO BUBBLES WERE OBSERVED IN THE PFO TALISMAN DEVICE DURING PREPARATION, BUT BUBBLES WERE INTRODUCED INTO THE PATIENT AS THE LEFT DISC WAS DEPLOYED. NO AIR BUBBLES WERE NOTED IN THE LOADER OR HEMOSTASIS VALVE OF THE TALISMAN PFO OCCLUDER. THE PATIENT WAS TREATED WITH MEDICATION WHILE WAITING FOR THE AIR TO CLEAR. AFTER STABILIZATION AND RESOLUTION OF THE AIR EMBOLISM, THE PFO CLOSURE WAS COMPLETED

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 23570381 ↗
• MalfunctionNov 14, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, THE RIGHT ATRIAL DISC DEFORMED INTO A BOWL SHAPE AND DID NOT RETURN TO ITS NORMAL CONFIGURATION. AS A RESULT, THE PROCEDURE WAS ABORTED AND WILL BE ATTEMPTED ON ANOTHER DAY. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT, WITH NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23560716 ↗
• MalfunctionNov 7, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25- 18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING, THE RIGHT ATRIAL DISC BECAME DISTENDED AFTER PLACEMENT AND DID NOT LIE FLAT AGAINST THE SEPTUM. THEREFORE, THE OCCLUDER WAS RETRIEVED. THE DEFORMED DEVICE WAS NOT RELEASED FROM THE DELIVERY SYSTEM WHILE INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING A NEW 25- 18MM AMPLATZER TALISMAN PFO OCCLUDER. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY. 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 23499764 ↗