Amplatzer™ Talisman™ 9-TDS-08F45-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067033352), received between Nov 27, 2024 and Aug 8, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 8F AMPLATZER TALISMAN DELIVERY SHEATH WAS CHOSEN FOR A PROCEDURE. DURING SHEATH INSERTION, IT WAS NOTED THAT THE TIP OF THE SHEATH WAS ROLLED BACK AND COULD NOT BE INSERTED INTO THE BLOOD VESSEL. THE TIP OF THE SHEATH WAS REPORTEDLY CRUSHED AND KINK WAS NOTED. A NEW 8F AMPLATZER TALISMAN DELIVERY SHEATH WAS CHOSEN AND COMPLETED THE PROCEDURE. 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 DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748771 ↗
• MalfunctionJun 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR A PATENT FORAMEN OVALE (PFO) CLOSURE USING A 8F AMPLATZER TALISMAN DELIVERY SYSTEM. DURING THE DEVICE PREPARATION PRIOR TO IMPLANT, A BULBOUS DEFORMATION WAS NOTED ON THE OCCLUDER. THERE WERE NO BENDS OR KINKS BEEN OBSERVED IN THE DELIVERY SHEATH, HOWEVER, THE TIP CURLED UP DURING INSERTION, SO IT WAS REPLACED. A NEW 25-18MM AMPLATZER TALISMAN PFO OCCLUDER AND A NEW 8F AMPLATZER TALISMAN DELIVERY SYSTEM WERE CHOSEN AND COMPLETED THE PROCEDURE. 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 DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144988 ↗
• InjuryMay 30, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS SELECTED FOR IMPLANT USING A 8F AMPLATZER TALISMAN DELIVERY SYSTEM (DS). DURING THE PROCEDURE, THE DELIVERY SHEATH WAS POSITIONED IN THE RIGHT UPPER PULMONARY VEIN. WHILE THE PHYSICIAN WAS ATTEMPTING TO UNSHEATH THE LEFT DISC, WHEN THE DS CROSSED BACK TO THE RIGHT ATRIUM. AFTER RECAPTURING THE DEVICE, THE PHYSICIAN PULLED THE DEVICE BACK THROUGH THE SHEATH AND INTO THE DEVICE LOADER. ST ELEVATION WAS NOTED AT THIS TIME SIGNALING AN AIR INGRESS. THE PATIENT WAS PUT ON 5L O2 VIA NASAL CANNULA AND WAS COMPLAINING OF CHEST PRESSURE. THE PHYSICIAN PROCEEDED TO RE-CROSS THE PFO AND RESUME THE PROCEDURE. THE ST ELEVATION SUBSIDED AFTER APPROXIMATELY 3 MINUTES. THE PATIENT REMAINED STABLE FOR THE DURATION OF THE PROCEDURE. PHYSICIAN DID NOT STATE ANY COMPLAINT, ALLEGATION, OR FAULT WITH THE DEVICE OR THE DELIVERY SYSTEM. HE SUSPECTS THAT THERE WAS REDUCED BLOOD FLOW/BLEED BACK IN THE SHEATH EXCHANGE POSITION OF THE RIGHT UPPER PULMONARY VEIN AND THAT IS WHAT CONTRIBUTED TO THE AIR INGRESS. HE STATES THERE WAS ADEQUATE BLEED BACK DURING THE WET-TO-WET CONNECTION OF THE DEVICE AND DELIVERY SHEATH. THE DEVICE W

  Patient problems: Air Embolism

  MAUDE report 22115702 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT THE THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE MINOR BLEEDING WAS NOTED POST-PROCEDURE ON (B)(6) 2024. THE CAUSE OF THE PATIENT'S MINOR BLEEDING IS ATTRIBUTED TO PLACEMENT/USE OF THE 8F AMPLATZER TALISMAN DELIVERY SYSTEM. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20801123 ↗