Amplatzer TalismanRecalls & reported problems across all models

We found 6 models of Amplatzer Talisman by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 384 adverse event reports in the FDA's MAUDE database, received between Jan 12, 2022 and Sep 29, 2026 — classified as 3 deaths, 111 injuries, 270 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (236 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Amplatzer Talisman problems

Amplatzer Talisman models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Amplatzer™ Talisman™ 9-PFO-3025

  Transcatheter septal occluder
  1 death193 reports
• Amplatzer™ Talisman™ 9-PFO-2518

  Transcatheter septal occluder
  139 reports
• Amplatzer™ Talisman™ 9-PFO-3525

  Transcatheter septal occluder
  1 death25 reports
• Amplatzer™ Talisman™ 9-TDS-09F45-80

  Catheter, percutaneous
  1 death12 reports
• Amplatzer™ Talisman™ 9-PFO-1818

  Transcatheter septal occluder
  11 reports
• Amplatzer™ Talisman™ 9-TDS-08F45-80

  Catheter, percutaneous
  4 reports

Recent Amplatzer Talisman adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903204 ↗
• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903154 ↗
• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902419 ↗
• MalfunctionSep 22, 2026Difficult to Fold, Unfold or Collapse; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859392 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50848511 ↗
• MalfunctionSep 21, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848509 ↗
• 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 ↗
• InjurySep 17, 2026Patient Device Interaction Problem

  It was reported that on (b)(6) 2026, a 30-25mm Amplatzer Talisman PFO Occluder was chosen for implant. During the procedure, Heparin was administered and the patient's activated clotting time (ACT) was reported to be just below 250 seconds. Intracardiac echocardiography (ICE) was used for imaging guidance. Prior to device release, an acute, soft thrombus was observed on the distal cable. The thrombus was captured and pulled back with the device, and the device was subsequently removed. At the time of the procedure, no known hematologic disorder or systemic illness contributing to hypercoagulability had been identified, although a hematology workup was initiated. The procedure was aborted to allow for further hematologic evaluation. The patient remained stable and was subsequently discharged.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50801575 ↗
• MalfunctionSep 11, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741172 ↗
• MalfunctionAug 28, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6)2026, a 30-25mm Amplatzer Talisman PFO Occluder was chosen for implant using a 9F Amplatzer Talisman Delivery Sheath. During device positioning within the patient, it was observed that the right atrial disc appeared puffed up, resembling a cushion. This did not change after applying forward pressure with the delivery cable. 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. There was interaction with only septum during deployment. A new 30-25mm Amplatzer Talisman PFO Occluder was used 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 50506548 ↗
• MalfunctionAug 28, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50506434 ↗
• 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 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2026, a 30-25mm Amplatzer Talisman PFO Occluder was chosen for an implant. During the patent foramen ovale (PFO) closure procedure, there was no reported difficulty implanting the device itself; however, the physician experienced difficulty crossing the PFO defect. To facilitate crossing, an SL1 sheath was used to support a guidewire. Multiple wire and delivery sheath exchanges were performed during attempts to cross the PFO defect. The physician successfully crossed the PFO without any signs of issues. During the procedure, heparin was administered; however, the amount was unknown. The valve was not re-sheathed more than two times. The 25 mm Amplatzer Talisman PFO Occluder was subsequently delivered and released. Following device release, all delivery sheaths and wires were removed from the patient, and the venous access site was closed. While the patient was being transferred to a transport bed, the patient was noted to be unresponsive to nursing staff and was found to have a blood pressure of approximately 60/25 mmHg. The patient was returned to the catheterization laboratory table, where a circumferential pericardial effusion was identified. A pericard

  Patient problems: Pericardial Effusion

  MAUDE report 50261814 ↗
• MalfunctionAug 11, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216439 ↗

Other St. Jude Medical, Inc. products

• Tendril15 models · 49,498 reports
• Octrode10 models · 36,740 reports
• Proclaim12 models · 35,038 reports · 17 recalls
• Durata28 models · 19,805 reports
• Assurity MRI2 models · 17,838 reports · 1 recall
• Gallant8 models · 12,885 reports · 5 recalls
• Quartet10 models · 11,001 reports
• MitraClip19 models · 9,056 reports · 2 recalls