Amplatzer™ Trevisio™ 9-ATV08F45/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05415067030924), received between May 9, 2021 and Dec 3, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 8F AMPLATZER TREVISIO DELIVERY SYSTEM WAS CHOSEN FOR A PROCEDURE. DURING PREPARATION, WHILE AN AMPLATZER SEPTAL OCCLUDER DEVICE WAS BEING LOADED INTO THE 8F AMPLATZER TREVISIO DELIVERY SYSTEM, A LEAK OR SPURTING WAS OBSERVED FROM WHAT WAS INITIALLY THOUGHT TO BE THE CONNECTION OF THE TAP. HOWEVER, IT WAS LATER NOTED THAT THE OCCURRENCE WAS VERY PROXIMAL TO THE CONNECTION OF THE THREE-WAY TAP. A SMALL VISIBLE HOLE WAS IDENTIFIED, AND AS THE SYSTEM WAS FLUSHED, SALINE WAS SEEN COMING OUT FROM THE SIDE, JUST BELOW THE TAP ON THE TUBING. THE PHYSICIAN DECIDED TO USE THE SAME DELIVERY SYSTEM AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY OCCURRED, AND NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708806 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8F AND 9F AMPLATZER TREVISIO DELIVERY SYSTEMS WERE SELECTED FOR A PROCEDURE. DURING PREPARATION, ISSUES WERE OBSERVED SEQUENTIALLY WITH BOTH SYSTEMS. THE EXTENSION TUBING WERE SPRAYING AND LEAKING BELOW THE LOCKS. PECIFICALLY, THE EXTENSION TUBING ON EACH SYSTEM EXHIBITED LEAKAGE IN THE FORM OF A SALINE SPRAY, WITH AN ESTIMATED VOLUME OF APPROXIMATELY 20 ML. NO VISIBLE DAMAGE WAS NOTED ON THE TUBING OR OTHER COMPONENTS. A PRE-USE INSPECTION OF BOTH DELIVERY SYSTEMS WAS PERFORMED, AND NO ABNORMALITIES WERE IDENTIFIED AT THAT TIMETHE PROCEDURE WAS COMPLETED USING A 12 F AMPLATZER TREVISIO 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 23570967 ↗
• MalfunctionSep 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE COBRA DEVICE DEFORMATION OCCURRED WHILE EXPANDING THE DEVICE WITHIN THE PATIENT'S ANATOMY. THE DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY PRIOR TO BEING RELEASED FROM THE DELIVERY CABLE. A NEW 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN USING THE SAME DELIVERY SYSTEM, A COBRA DEVICE DEFORMATION OCCURRED AGAIN. THE DEFORMED DEVICE WERE RETRIEVED OUTSIDE THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. IT WAS OBSERVED THAT A THROMBUS HAD DEVELOPED ON THE 8F DELIVERY SYSTEM. THE THROMBUS DID NOT HAVE UNUSUAL OR FIBER LIKE APPEARANCE. IT WAS NOTED THAT THE SHEATH WAS IN THE PATIENT FOR A SIGNIFICANT PERIOD OF TIME DUE TO THE DEFORMATIONS. THE ACTIVATED CLOTTING TIME (ACT) LEVEL WAS NOTED AS 250 DURING THE PROCEDURE, HOWEVER IT WAS NOTED THAT IT WAS DIFFICULT TO PROLONG AND ADDITIONAL HEPARIN WAS ADMINISTERED. THE PATIENT DID NOT HAVE ANY HEMATOLOGICAL DISORDERS OR SYSTEMIC ILLNESS TO CONTRIBUTE TO THE HYPERCOAGULABILITY. THE PROCEDURE WAS COMPLETED USING AN 8MM AMPLATZER SEPTAL OCCLUDER AND NEW DELIVER S

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23136450 ↗
• MalfunctionJun 17, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (ATV) DURING PROCEDURE, A 6FR SHORT 10CM SHEATH INSERTED, DILATED TO 8FR, A 24MM SIZING BALLOON WAS INSERTED SHEATH LESS WITHOUT ISSUE. THE DEFECT WAS SIZED AND 8FR AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS CHOSEN. WHEN INSERTING THE 8FR TREVISIO THERE WAS A DIFFICULTY EXPERIENCED TRYING TO ADVANCE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED AND BURR SEEN AT THE TIP. A NEW 8F AMPLATZER TALISMAN DELIVERY SHEATH WAS OPENED AND PASSED WITHOUT ISSUE. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233578 ↗
• MalfunctionJan 3, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT A 19MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, AFTER DEPLOYING THE LEFT ATRIAL DISC AND PULLING IT TOWARDS THE SEPTUM, THE OCCLUDER WAS OBSERVED TO HAVE PRE-MATURELY DISCONNECTED FROM THE DELIVERY CABLE WHILE ATTEMPTING TO RETRACT THE OCCLUDER BACK TO THE RIGHT ATRIUM. ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) A COMPRESSION OF THE AORTIC ROOT WAS SEEN. THE DELIVERY SYSTEM WAS REPLACED WITH A NEW 12F NON-ABBOTT GUIDING SHEATH. THE OCCLUDER WAS SNARED AND REMOVED FROM THE PATIENT. THE SAME OCCLUDER WAS ATTEMPTED TO BE CONNECTED TO THE 12F SHEATH, BUT IT DISCONNECTED WHILE ATTEMPTING TO PULL IT INTO THE SHORT SHEATH. THE OCCLUDER WAS REPLACED WITH A NEW 20MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072200 ↗
• InjuryJul 26, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A 16MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE PATIENT WAS UNDER CONSCIOUS SEDATION. DURING THE PROCEDURE THE DELIVERY SYSTEM WAS ASPIRATED PRIOR TO INSERTION OF THE OCCLUDER. THE CONTINUOUS FLUSH WAS ATTACHED TO THE Y-PORT OF THE DELIVERY SYSTEM. DURING IMPLANT THE LEFT ATRIAL DISC OF THE DEVICE TOOK ON A COBRA SHAPE. DURING RE-DEPLOYMENT THE PATIENT EXPERIENCED AN ST ELEVATION, FOLLOWED BY BRADYCARDIA AND A DROP IN BLOOD PRESSURE. ADRENALIN AND ATROPINE WERE ADMINISTERED. THE PATIENT RE-STABILIZED WITHIN 5 MINUTES. THE DEVICE WAS RE-CAPTURED AND RE-DEPLOYED BUT THE COBRA SHAPE PERSISTED. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 17MM AMPLATZER SEPTAL OCCLUDER. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. NO LEAKS WERE OBSERVED. THE PHYSICIAN SUSPECTED AN AIR EMBOLISM CAUSED THE ST ELEVATION. NO AIR WAS VISUALIZED IN THE PATIENT, HOWEVER LOW LEFT ATRIAL PRESSURE AND ADVANCING AIR INTO THE PATIENT'S HEART ALONG WITH THE DEVICE WAS ATTRIBUTED TO THE AIR EMBOLISM. THE PATIENT STATU

  Patient problems: Air Embolism; Bradycardia; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 19841758 ↗
• MalfunctionMay 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM AMPLATZER PFO OCCLUDER WAS CHOSEN FOR IMPLANT WITH AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE DELIVERY SYSTEM DEVICE PREPARATION, IT WAS NOTICED THAT THE THREE-WAY STOPCOCK WAS DAMAGED AND THE "BLUE TAP PART HAD BECOME DETACHED FROM THE THREE WAY PART." IT WAS REPORTED THE OPERATOR REPLACED THE THREE WAY TAP WITH A GENERIC ALTERNATIVE. THERE WAS NO REPORT OF ANY DAMAGE TO THE PRODUCT BOX PRIOR TO USE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16998947 ↗
• MalfunctionNov 11, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 14MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING PROCEDURE, WHEN DEPLOYED IN THE LEFT ATRIUM (LA), THE OCCLUDER DEFORMED INTO A COBRA SHAPE AND THE DELIVERY SYSTEM ALSO DEFORMED. THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW 16MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15777711 ↗
• InjuryMay 9, 2021Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2021, A AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM (DS) WAS USED IN PROCEDURE. THE USER REPORTS THAT THE 8 FR DS PRESENTED WITH DAMAGE, STATING THE SHEATHS DISTAL END BROKE WHICH DID NOT ALLOW THE DEVICE TO ADVANCE PROPERLY AND REPORTED THE SHEATH¿S DISTAL END WAS " DEFORMED" AT THE MOMENT OF THE FEMORAL VASCULAR ACCESS. A HEMATOMA ON THE VASCULAR ACCESS SITE WAS A REPORTED COMPLICATION. THE HEMATOMA RESOLVED WITH LOCAL PRESSURE AND TRANSITORY FEMORAL INTRODUCER HOWEVER IT IS IN THE PHYSICIANS OPINION THAT THE PATIENT EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT.

  Patient problems: Hematoma

  MAUDE report 11795597 ↗