Amplatzer™ Talisman™ 9-TDS-09F45-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05415067033369), received between Feb 19, 2024 and Sep 11, 2026 — classified as 1 death, 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741172 ↗
• DeathAug 25, 2026Difficult to Advance; Material Twisted/Bent

  It was reported that on (b)(6) 2026, an Amplatzer Vascular Plug II was chosen for implant using a 9F Amplatzer Talisman Delivery Sheath. The device properly flushed and prepared according to the IFU before attempting delivery. Prior to the procedure, the patient was reported to be stable. During the procedure, while attempting to advance the occluder, resistance was encountered and the sheath kinked. No difficulty implanting the device, such as multiple manipulations, was reported. Following the procedure on an unknown date, a pericardial effusion developed. Subsequently, the patient experienced tamponade and died after the operation. The date and cause of death was reported as unknown; however, it was thought to be due to wire perforation and cardiac tamponade.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50439736 ↗
• MalfunctionFeb 23, 2026Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F TALISMAN DELIVERY SYSTEM. DURING THE PROCEDURE, A BRIEF ST-ELEVATION WAS OBSERVED ON THE EKG, AND AIR WAS NOTED ON THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AS REPORTED BY THE PHYSICIAN. THE PHYSICIAN CONFIRMED THAT THIS FINDING REPRESENTED AN AIR EMBOLISM, AND THE AIR WAS VISUALIZED IN THE LEFT ATRIUM. THE EVENT OCCURRED AFTER THE GUIDEWIRE AND DILATOR WERE REMOVED, AT WHICH POINT AIR BECAME VISIBLE. THE PHYSICIAN NOTED THAT THE PATIENT BREATHED AT THAT MOMENT, PRIOR TO CONNECTING THE LOADER, AND THIS SEQUENCE OF EVENTS PRECEDED ESTABLISHMENT OF THE WET-TO-WET CONNECTION BETWEEN THE SHEATH AND THE LOADER. FOLLOWING THIS OCCURRENCE, THE EKG RETURNED TO NORMAL. NO MEDICAL INTERVENTION OR MEDICATION WAS ADMINISTERED TO TREAT THE AIR EMBOLUS. THE PATIENT WAS UNDER CONSCIOUS SEDATION AT THE TIME OF THE EVENT. ADDITIONALLY, NO LEAK WAS NOTED IN THE DELIVERY SYSTEM, NO AIR WAS OBSERVED IN THE DEVICE DURING PREPARATION OR THE PROCEDURE, AND THE AMPLATZER TALISMAN PFO OCCLUDER WAS NEVER RETRACTED PRIOR TO DEPLOYMENT. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVI

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

  MAUDE report 24422797 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 9F AMPLATZER TALISMAN DELIVERY SYSTEM. AFTER IMPLANTATION, IT WAS OBSERVED THAT THERE WAS A LIVER BLEED NOTED IN THE PATIENT. IT WAS NOTED THAT THE CAUSE THAT LED TO THE BLEEDING WAS DUE TO DIFFICULTY IN ADVANCING THE ICE CATHETER. THERAPEUTIC HEPARIN WAS ADMINISTERED, AND BLOOD TRANSFUSION WAS REQUIRED TO TREAT THE EVENT. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24075005 ↗
• InjurySep 18, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED ON (B)(6) 2025 A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER USING A 9F AMPLATZER TALISMAN DELIVERY SHEATH TO TREAT A PATENT FORAMEN OVALE (PFO). THE PATIENT PRESENTED WITH CHALLENGING ANATOMY WITH AN EXTREMELY MOBILE INTERATRIAL SEPTUM. TRANSSEPTAL ACCESS WAS ANTERIOR IN FRONT OF THE PFO TUNNEL. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 250 SECONDS. DURING THE PROCEDURE IT WAS NOTED THAT THE OCCLUDER WAS TOO SMALL TO ADEQUATELY COVER THE PFO TUNNEL. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER. THE GUIDEWIRE WAS ADVANCED SLIGHTLY ANTERIOR TO THE PFO OPENING INTO THE LEFT ATRIUM. DURING DEPLOYMENT OF THE RIGHT ATRIAL DISC THE DELIVERY SHEATH WAS POSITIONED SOMEWHAT IN THE AORTIC ORIENTATION. DUE TO THE SEPTAL MOBILITY AND RECURRENT EPISODES OF ATRIAL FLUTTER, THE OCCLUDER COULD NOT BE POSITIONED OPTIMALLY WITHIN THE PFO TUNNEL. THE PROCEDURE WAS ABORTED. LATER THE SAME DAY THE PATIENT DEVELOPED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT STATUS WAS STABLE. THE USER BELIEVED THE DELIVERY SHEATH IRRITATED THE LEFT ATRIAL WALL DUE TO THE PATIENT'S SEPTAL MOBILITY AND ATRIAL FLUTTE

  Patient problems: Atrial Flutter; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23085552 ↗
• InjurySep 15, 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 PFO OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SYSTEM TO TREAT A PATENT FORAMEN OVALE (PFO). DURING THE PROCEDURE ST ELEVATIONS WERE NOTED. BUBBLING WAS OBSERVED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE); HOWEVER, IT WAS UNKNOWN WHETHER IT WAS DUE TO IRRIGATION VIA ADVANCEMENT OF THE DELIVERY SYSTEM OR AIR. THE PROCEDURE WAS ABORTED. THE ST ELEVATIONS RESOLVED ON ITS OWN. THE PATIENT STATUS WAS STABLE.

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

  MAUDE report 23054961 ↗
• MalfunctionJul 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT ONE (B)(6) 2025, A 25-18MM AMPLATZER TALISMAN PATENT FORAMEN OVALE (PFO) OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SHEATH. IT WAS NOTED DURING PROCEDURE WHEN TIGHTENING OF COMPONENT OF THE DELIVERY SHEATH, THAT THE DILATOR BROKE DURING LOOSENING AND PRIOR TO REMOVAL OF THE DILATOR AND WIRE. AT THE TIME OF THE BREAK, THE COMPONENT BEING TIGHTENED WAS THE CONNECTOR BETWEEN THE DILATOR AND THE DELIVERY SHEATH. THE DECISION WAS MADE TO REMOVE THE 9F AMPLATZER TALISMAN DELIVERY SHEATH AND REPLACE IT WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, AND THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SIGNS OR SYMPTOMS DURING OR AFTER THE EVENT. ADDITIONALLY, NO LEAK WAS OBSERVED IN THE 9F AMPLATZER TALISMAN DELIVERY SHEATH. THE PATIENT WAS STABLE THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22570875 ↗
• InjuryJul 4, 2025Air/Gas in Device; Air/Gas in Device

  N/A

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

  MAUDE report 22403779 ↗
• MalfunctionApr 17, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9F AMPLATZER TALISMAN DELIVERY SYSTEM WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE DELIVERY SHEATH WAS DIFFICULT TO INSERT TO THE VEIN. WHEN IT WAS PULLED OUT AGAIN, THE DEFORMATIONS WERE VISIBLE, AND TO PREVENT INJURY, A NEW DELIVERY SHEATH WAS DECIDED TO USED. A NEW 8F AMPLATZER TALISMAN DELIVERY SYSTEM WAS CHOSEN AND INSERTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857865 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_806 - PFO OCCLUDER PAS, PATIENT SITE ID: (B)(6) (R852733701). IT WAS REPORTED THAT ON 15 JULY 2024, A 9F AMPLATZER TALISMAN DELIVERY SYSTEM WAS SELECTED FOR PROCEDURE. THERE WAS NO PERFORMANCE ISSUES WITH THE 9F AMPLATZER TALISMAN DELIVERY SYSTEM. ON THE SAME DAY IT WAS NOTED POST-DISCHARGED, THAT THE PATIENT HAD SOAKING BLOOD AT THE ACCESS SITE OF THE DELIVERY SYSTEM. THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT AND PRESSURE WAS APPLIED TO THE BLEEDING CLOSURE/ACCESS SITE FOR 5 MINUTES. THE PATIENT HAD AN INTERNATIONAL NORMALIZED RATIO OF 1.1. THE DECISION WAS MADE TO PLACE PRESSURE DRESSING AND A SALINE BAG OVER THE BLEEDING CLOSURE/ACCESS SITE TO STOP THE BLEEDING. AN ULTRASOUND WAS PERFORMED TO RULE OUT POSSIBLE OF PSEUDOANEURYSM. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE DELIVERY SYSTEM OR PROCEDURE. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19994005 ↗
• MalfunctionAug 13, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 9F AMPLATZER TALISMAN DELIVERY SYSTEM WAS SELECTED FOR USE TO IMPLANT AN UNKNOWN SIZED AMPLATZER PFO OCCLUDER. THE DELIVERY SYSTEM HAD DIFFICULTY INSERTING INTO THE ACCESS SITE AT THE FEMORAL AREA. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND IT WAS OBSERVED THAT THE TIP OF THE SYSTEM WAS FLARED; THE PHYSICIAN ALLEGED THAT EXCESSIVE FORCE WAS THE CAUSE OF THE FLARING. THE TIP WAS NOT TORN/RIPPED. A NEW 9F AMPLATZER TALISMAN DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND NO CLINICALLY SIGNIFICANT PROLONGED PROCEDURE WAS REPORTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974068 ↗
• InjuryFeb 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR A PATENT FORAMEN OVALE (PFO) CLOSURE USING A 9F AMPLATZER TALISMAN DELIVERY SHEATH. HEPARIN WAS ADMINISTRATED AT THE BEGINNING OF THE PROCEDURE. DURING PROCEDURE, A THROMBUS WAS NOTED ON THE DISTAL SIDE OF THE DELIVERY SHEATH. THE THROMBUS WAS OVER 1CM AND FIBER-LIKE SHAPE. THE SHEATH WAS IN THE PATIENT FOR 2-3 MINUTES. THE PHYSICIAN WAS ABLE TO ASPIRE THE SHEATH BUT THE RIGHT SIDE OF THE DEVICE HAD A BULBOUS SHAPE. THE PHYSICIAN FLUSHED THE DEVICE AFTER THE ASPIRATION OF THE THROMBUS BUT THERE WAS A SMALL PART OF THROMBUS THAT COULDN'T BE REMOVED. A DECISION WAS TAKEN TO REPLACE THE DEVICE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. A NEW 30MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT HAD BEEN COMPLIANT W

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18732297 ↗