Amplatzer™ Trevisio™ 9-ATV07F45/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05415067030900), received between Oct 9, 2020 and Sep 29, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941144 ↗
• MalfunctionSep 11, 2026Difficult to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741119 ↗
• MalfunctionJul 6, 2026Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 7F AMPLATZER TREVISIO DELIVERY SYSTEM WAS CHOSEN FOR A PROCEDURE. THE DEVICE WAS PROPERLY FLUSHED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT UNDERWENT FEMORAL ACCESS USING A STANDARD FEMORAL INTRODUCER, FOLLOWED BY PRIOR DILATION USING THE DILATOR FROM THE FEMORAL PUNCTURE KIT. THE SHEATH HAD NOT BEEN INSPECTED PRIOR TO USE. DURING INSERTION THROUGH THE PATIENT¿S SKIN IN THE RIGHT FEMORAL REGION, RESISTANCE WAS ENCOUNTERED DESPITE PRIOR DILATION, AT WHICH TIME A DEFECT WAS NOTED. DURING ADVANCEMENT OF THE SHEATH THROUGH THE FEMORAL ACCESS, DEFORMATION OF THE DISTAL END OF THE SHEATH WAS OBSERVED AFTER CONTACT WITH TISSUE ALONG THE PUNCTURE PATH, WITH SMALL ¿TEETH-LIKE¿ DEFORMITIES IDENTIFIED AT THE TIP OF THE SHEATH. DEVICE CONTACT WITH THE PATIENT WAS LIMITED TO THIS INITIAL INSERTION ATTEMPT, WITH NO ADVANCEMENT OF THE SYSTEM THEREAFTER. NO INTERACTION WITH CARDIAC STRUCTURES OCCURRED, AND NO ANGULATION OR KINKING OF THE DELIVERY SYSTEM WAS OBSERVED. TO MITIGATE THE RISK OF VASCULAR COMPLICATIONS, INCREASED FRICTION, POTENTIAL DEVICE DAMAGE, AND IMPLANT FAILURE, THE INITIAL SHEATH WAS NOT USED FURTHER. A SECOND SHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25725137 ↗
• MalfunctionMar 13, 2026Retraction Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 10MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING DEPLOYMENT, THE LEFT ATRIAL DISC WAS OBSERVED TO TAKE ON A COBRA-TYPE CONFIGURATION, AND THE DEVICE WAS SUBSEQUENTLY REMOVED WITHOUT BEING RELEASED FROM THE DELIVERY CABLE. THE PROCEDURE THEN CONTINUED WITH THE SELECTION AND PLACEMENT OF AN 11 MM AMPLATZER SEPTAL OCCLUDER. DURING TRANSESOPHAGEAL ECHOCARDIOGRAPHIC ASSESSMENT, THE DEVICE APPEARED OVERSIZED. WHEN AN ATTEMPT WAS MADE TO RECAPTURE THE DEVICE, IT COULD NOT BE FULLY WITHDRAWN INTO THE 7 F AMPLATZER TREVISIO DELIVERY SYSTEM. THE DECISION WAS MADE TO RELEASE THE DEVICE AND MONITOR THE PATIENT CLOSELY. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597469 ↗
• MalfunctionOct 29, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2025, A 7F AMPLATZER TREVISIO DELIVERY SYSTEM WAS SELECTED FOR USE. DURING USE, AFTER INSERTION INTO THE PATIENT, AS THE OCCLUDER WAS BEING LOADED, IT WAS NOTED THAT THERE WAS A LEAK COMING FROM WHAT WAS INITIALLY THOUGHT AS THE CONNECTION OF THE TAP AND THE 3-WAY TAP WAS EXCHANGED. HOWEVER, IT WAS THEN NOTED THAT "VERY PROXIMAL TO THE CONNECTION OF THE 3 WAY TAP" WAS A SMALL VISIBLE HOLE THAT WAS LEAKING SALINE OUT THE SIDE "JUST BELOW THE TAP." THE USER WAS OFFERED TO EXCHANGE THE DEVICE, HOWEVER THE PHYSICIAN ELECTED TO PROCEED AND THE DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410630 ↗
• MalfunctionJul 24, 2025Retraction Problem; Retraction Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591663 ↗
• MalfunctionAug 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2024 A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (ATV) WAS SELECTED TO IMPLANT A DEVICE. DURING PREPARATION OF THE DELIVERY SYSTEM, THERE WAS LEAKAGE FROM THE SIDE OF THE TIP TUBE PART WAS OBSERVED WHEN FLASHING THE LOADER. CONTINUOUS DRIP BORDER BETWEEN THE TUBE AND THE DIAL. THE PROCEDURE WAS CONTINUED AND COMPLETED. NO HEALTH IMPACT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983746 ↗
• MalfunctionNov 14, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (ATV) WAS CHOSEN FOR A PROCEDURE. DURING THE PREPARATION, WHILE RINSING IT WAS NOTED THAT THE Y PIECE, OR HEMOSTASIS VALVE, OF THE DEVICE WAS SCREWED ON TIGHTLY, AND AIR WAS DRAWN THROUGH THE Y PIECE. THE DELIVERY SYSTEM DID NOT MAKE PATIENT CONTACT. A NEW 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS CHOSEN AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT ISSUE. 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 18131332 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 6MM BY 4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO DELIVERY SYSTEM. THE PURPOSE OF THE PROCEDURE WAS CLOSURE OF A GERBODE DEFECT. THE PHYSICIAN ATTEMPTED TO PLACE THE RAIL GUIDEWIRE AND LOADER THROUGH THE DELIVERY SYSTEM BUT THERE WAS DIFFICULTY GETTING THE LOADER TO FIT ALONG THE WIRE. THE WIRE WAS REMOVED AND THE OCCLUDER WAS ADVANCED THROUGH THE DELIVERY SYSTEM WITHOUT ISSUES. AT THE END OF THE PROCEDURE, A FULL ECHOCARDIOGRAM (ECHO) ASSESSMENT WAS PERFORMED AND SHOWED WHAT THEY THOUGHT WAS A LOOSE CHORDAE TENDINEAE. IT WAS UNKNOWN IF THE CHORDAE TENDINEAE WERE DAMAGED BY EITHER ABBOTT DEVICE. THE OVERALL FUNCTION OF THE MITRAL VALVE REMAINED UNCHANGED FROM THE BEGGING OF THE CASE TO THE END OF THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17168195 ↗
• MalfunctionFeb 22, 2023Retraction Problem; Contamination /Decontamination Problem; Retraction Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 11MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED AS USUAL WITH USE OF A 7F AMPLATZER TREVISIO DELIVERY SYSTEM. THE PHYSICIAN DID NOT ENCOUNTER ANY DIFFICULTY OR RESISTANCE WITH THE DEVICE IMPLANT. AFTER THE ASO WAS IMPLANTED IN THE DEFECT, THE DELIVERY CABLE WAS DETACHED FROM THE ASO WITHOUT ANY ISSUE. WHEN THE DELIVERY CABLE WAS BEING PULLED INTO THE TREVISIO DELIVERY SHEATH, RESISTANCE WAS FELT. AFTER PULLING OUT FROM THE PATIENT, FIBROUS FORM LIKE SUBSTANCES WAS VISUALLY CONFIRMED ADHERING ONTO 1-2CM OF THE TIP OF THE DELIVERY CABLE. THE PHYSICIAN ALLEGED THAT ALTHOUGH THE ASO WAS ABLE TO BE DETACHED FROM THE DELIVERY CABLE AS USUAL, RESISTANCE WAS FELT WHILE THE DELIVERY CABLE WAS PULLED INTO THE DELIVERY SHEATH. SO THE POLYESTER FIBER MIGHT HAVE BEEN ACCIDENTALLY TANGLED BY THE CABLE. AT PRESENT, NO FINDINGS HAVE BEEN CONFIRMED UNDER ECHO OBSERVATION AND FLUOROSCOPY OF THE ASO AFTER PLACEMENT. THE PRODUCT BOX CONTAINING THE DELIVERY SYSTEM DID NOT APPEARED DAMAGED IN ANY WAY. PATIENT STABLE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421119 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, A 6MM AMPLATZER DUCT OCCLUDER AND A 6/4MM AMPLATZER DUCT OCCLUDER II WERE IMPLANTED. POST-IMPLANT, VASCULAR HEMATOMA AND ACTIVE BLEEDING FROM THE LEFT FEMORAL PUNCTURE SITE WAS OBSERVED AND MANUAL COMPRESSION WAS APPLIED. OF NOTE, AN EPISODE OF HYPOTENSION WAS OBSERVED AND RELATED TO THE BLEEDING. THE PATIENT WAS TRANSFUSED 1 UNIT OF PACKED RED BLOOD CELLS. NO PATIENT CONSEQUENCES WERE REPORTED. ON (B)(6) 2021, ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE 7F AMPLATZER TREVISIO DELIVERY SYSTEM (BATCH/LOT: 7507123) WAS USED IN THE LEFT ACCESS SITE. AN ADDITIONAL 6MM AMPLATZER DUCT OCCLUDER (BATCH/LOT: 6987723) WAS ATTEMPTED TO BE IMPLANTED, HOWEVER THE OCCLUDER EMBOLIZED TO THE PULMONARY ARTERY AND WAS RETRIEVED VIA SNARE. IN ADDITION, THE 5MM AMPLATZER DUCT OCCLUDER (BATCH/LOT: 7456394) WAS MIS-SIZED. CLINICAL STUDY PATIENT ID: (B)(6).

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 11806312 ↗
• MalfunctionDec 15, 2020Material Twisted/Bent; Material Twisted/Bent

  AFTER HAVING DEPLOYED AN ASD DEVICE IN COBRA SHAPE, THE PHYSICIAN HAS REMOVED THE DELIVERY SYSTEM AND DEVICE OUT OF THE PATIENT. THEN HE NOTICED THE LITTLE KINK AT THE TIP OF THE DELIVERY SYSTEM. BY CHANGING THE DS, THE SAME DEVICE COULD BE DEPLOYED IN A PROPER WAY. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11012547 ↗
• MalfunctionOct 9, 2020Material Deformation; Material Deformation

  RELATED MANUFACTURER REFERENCE NUMBER : 2135147-2020-00435.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10658241 ↗