Amplatzer TrevisioRecalls & reported problems across all models

We found 6 models of Amplatzer Trevisio by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2020 and Sep 29, 2026 — classified as 1 death, 22 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (14 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 Trevisio problems

Amplatzer Trevisio models

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

• Amplatzer™ Trevisio™ 9-ATV09F45/80

  Catheter, percutaneous
  25 reports
• Amplatzer™ Trevisio™ 9-ATV07F45/80

  Catheter, percutaneous
  13 reports
• Amplatzer™ Trevisio™ 9-ATV10F45/80

  Catheter, percutaneous
  1 death12 reports
• Amplatzer™ Trevisio™ 9-ATV08F45/80

  Catheter, percutaneous
  9 reports
• Amplatzer™ Trevisio™ 9-ATV12F45/80

  Catheter, percutaneous
  7 reports
• Amplatzer™ Trevisio™ 9-ATV07F45/60

  Catheter, percutaneous
  5 reports

Recent Amplatzer Trevisio adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 28, 2026Fluid/Blood Leak

  It was reported on (b)(6) 2025, a 9F Amplatzer Trevisio Intravascular Delivery System was chosen for a procedure. During the device preparation, while flushing the device, it was noted that a leak was observed at the Y-connector thread. The flushing of the device was performed according to the Instructions for Use (IFU). The delivery system had been inspected prior to use, and no cracks or other abnormalities were observed. No damage to the product packaging was noted before opening, and no cracks or damage were observed on the delivery system. The device had not been handled or manipulated prior to the observation of the leakage. The reported leakage was less than 200 mL and did not result in any blood loss. Despite the leakage, the procedure was completed successfully using the same device. 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 50505779 ↗
• MalfunctionAug 12, 2026Fluid/Blood Leak; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229620 ↗
• MalfunctionJul 17, 2026Retraction Problem; Material Deformation

  IT WAS REPORTED THAT ON (b)(6) 2026, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. PRIOR TO PROCEDURE, IT WAS DETERMINED THAT THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. THE DEVICE WAS PROPERLY FLUSHED AND PREPARED ACCORDING TO THE IFU BEFORE THE DELIVERY ATTEMPT. DURING THE PROCEDURE, THE DELIVERY CABLE WAS ALIGNED WITH THE DISC, AND THE DEVICE WAS DEPLOYED IN THE PATIENT¿S ANATOMY. AFTER ASSESSING THE DEVICE POSITION WITHIN THE SEPTUM, THE PHYSICIAN DECIDED TO RETRIEVE THE DEVICE FOR REPOSITIONING; HOWEVER, THE RETRIEVAL ATTEMPT WAS UNSUCCESSFUL, AND ONLY THE RIGHT DISC COULD BE RECAPTURED. THE PHYSICIAN SUBSEQUENTLY REDEPLOYED THE RIGHT DISC AND RELEASED THE DEVICE. IT WAS NOTED DURING THE PROCEDURE THAT THE DISTAL TIP OF THE DELIVERY SYSTEM WAS DAMAGED. 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 25861902 ↗
• 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 ↗
• MalfunctionApr 27, 2026Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 9F AMPLATZER TREVISO DELIVERY SYSTEM WAS CHOSEN FOR A PROCEDURE. DURING DEVICE PREPARATION AND FLUSHING PERFORMED IN ACCORDANCE WITH THE IFU, IT WAS NOTED THAT THE DELIVERY SHEATH AND TOUHY WERE LEAKING, WITH A CONSTANT SALINE LEAK OBSERVED DURING FLUSHING. AIR WAS ALSO NOTED WITHIN THE SYSTEM DURING THE DE-AIRING PROCESS, WHICH MADE PREPARATION CHALLENGING. THE DEVICE WAS INSPECTED PRIOR TO USE, NO CRACK, DAMAGE, OR ABNORMALITIES WERE NOTED, AND THERE WAS NO DAMAGE OBSERVED TO THE PRODUCT PACKAGING PRIOR TO OPENING. THE DEVICE DID NOT INITIALLY COME IN DIRECT CONTACT WITH THE PATIENT; HOWEVER, A FLUSH BAG OF SALINE WAS ATTACHED TO THE SHEATH TO PROVIDE FORWARD PRESSURE AND PREVENT FURTHER AIR INGRESS, AFTER WHICH BLOOD LEAKAGE WAS OBSERVED WHEN THE SYSTEM WAS CONNECTED TO THE PATIENT. THE LEAKAGE WAS DESCRIBED AS A CONTINUOUS DRIP, NOT EXCEEDING 200 ML, AND NO CLINICALLY SIGNIFICANT BLOOD LOSS OCCURRED. NO DAMAGED COMPONENTS OR CRACKS WERE IDENTIFIED IN THE DELIVERY SYSTEM. THE DEVICE WAS SUBSEQUENTLY RESIZED AND EXCHANGED, AND THE PROCEDURE WAS COMPLETED USING A NEW TALISMAN DEVICE, WITH THE TALISMAN DELIVERY WIRE AND TOUHY USED IN PLACE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010358 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, A 9F AMPLATZER TREVISIO DELIVERY SYSTEM WAS CHOSEN FOR THE PROCEDURE. DURING DEVICE PREPARATION, IT WAS NOTED THAT THE THERE WAS A LEAK OBSERVED AT THE LEVEL OF THE STOPCOCK. THE LEAK WAS NOTED TO BE SALINE WHICH WAS USED FOR FLUSHING. THERE WAS NO DAMAGE OBSERVED ON THE PRODUCT PACKAGING. IT WAS ALSO REPORTED THAT THE STOPCOCK SCREW THREAD APPEARED DAMAGED WHICH LED TO THE LEAK AT THE LEVEL OF THE STOPCOCK. THERE WAS NO CRACK OR MATERIAL DEFORMATION OBSERVED. THE PROCEDURE WAS COMPLETED USING A NEW 8F 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 24718765 ↗
• MalfunctionMar 20, 2026Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 9F AMPLATZER TREVISIO DELIVERY SYSTEM WAS CHOSEN FOR A PROCEDURE. DURING DEVICE PREPARATION, THE DEVICE WAS INSPECTED WITH NO CRACK NOTED AT THAT TIME. WHILE FLUSHING THE SIDE ARM IN ACCORDANCE WITH THE IFU, A LEAK WAS OBSERVED FROM THE SIDE ARM, AND A CRACK AT THE CONNECTION WAS SUBSEQUENTLY IDENTIFIED AT THE TIME, OF FLUSHING. THE LEAK OCCURRED DURING THE FIRST 30 ML SYRINGE FLUSH, WITH APPROXIMATELY 15 ML INFUSED WHEN THE LEAK WAS NOTED. NO HANDLING OR MANIPULATION BEYOND STANDARD PREPARATION OCCURRED PRIOR TO THE OBSERVATION, AND NO ADDITIONAL COMPONENTS OF THE DELIVERY SYSTEM WERE OBSERVED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING A 9F AMPLATZER TORQVUE EXCHANGE SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY OR ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651801 ↗
• 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 ↗
• InjuryDec 30, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30-25MM AMPLATZER TALISMAN PFO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. THE INITIAL PREPARATION OF THE PFO OCCLUDER DEVICE WAS PERFORMED CORRECTLY, ENSURING ALL AIR WAS REMOVED FROM THE LOADER AND SYSTEM. ONCE THE DEVICE WAS ATTACHED AND INSERTED INTO THE DELIVERY SYSTEM AND ADVANCED APPROXIMATELY HALFWAY THROUGH THE SHEATH, THE PATIENT EXHIBITED ST ELEVATIONS DUE TO AN AIR EMBOLISM. THE PHYSICIAN RETRACTED THE DEVICE BACK INTO THE LOADER, DETACHED IT, AND REMOVED IT FROM THE PATIENT. ON THE BACK TABLE, WHILE ATTEMPTING TO FLUSH AND RE-PREPARE THE DEVICE, THE TUOHY ATTACHED TO THE LOADER DID NOT FULLY SEAL. THE TECHNICIAN ATTEMPTED TO TROUBLESHOOT THE TUOHY TIGHTNESS; HOWEVER, EVEN WHEN TIGHTENED AS MUCH AS POSSIBLE, THE TUOHY CONTINUED TO LEAK SALINE. THE PROCEDURE WAS COMPLETED USING A NEW 30¿25 MM AMPLATZER TALISMAN PFO OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, AND NO ADVERSE EFFECTS WERE OBSERVED.

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

  MAUDE report 23927239 ↗
• 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 ↗
• DeathDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, AN AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO DELIVERY SYSTEM. ITHE INTENDED PROCEDURE WAS PERCUTANEOUS POST MI VSD CLOSURE. IT WAS NOTED THAT THE PATIENT DECOMPENSATED DURING THE ADVANCEMENT OF THE DELIVERY SHEATH DUE TO AN INCREASE IN RIGHT HEART OVERLOAD. PRIOR TO THE PROCEDURE, THE PATIENT WAS UNSTABLE, ON MULTIPLE LIFE-SUPPORTING INOTROPIC AGENTS, INTUBATED, AND SEDATED. THE PATIENT HAD SEVERE HEART FAILURE WITH VENTRICULAR DYSFUNCTION AND CARDIOGENIC SHOCK POST-MI, ALONG WITH MULTI-SYSTEM ORGAN FAILURE. THERE WAS NO PRODUCT CONCERN AND NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR THE PROCEDURE. THE DEVICE WAS NEVER IMPLANTED. THE INCREASE IN RIGHT HEART OVERLOAD WAS THOUGHT TO HAVE OCCURRED BECAUSE, DURING ADVANCEMENT OF THE DELIVERY SHEATH, THE TRICUSPID VALVE AND INFARCT AREA WERE HELD OPEN BY THE SHEATH, WHICH CAN EXACERBATE LEFT-TO-RIGHT SHUNTING AND RV OVERLOAD. THE DELIVERY SHEATH ADVANCEMENT WAS SLOW AS IT WAS MANIPULATED OVER THE AV LOOP WIRE AND CROSSED INTO THE LV. THE PATIENT DID NOT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AS DECOMPENSATION OCCURRED DURING THE ATT

  Patient problems: Cardiac Arrest

  MAUDE report 23687553 ↗
• MalfunctionNov 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660523 ↗
• MalfunctionNov 25, 2025Retraction Problem; Retraction Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649423 ↗

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