Amplatzer™ Trevisio™ 9-ATV07F45/60Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067030894), received between Oct 11, 2023 and Jul 17, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Retraction Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMar 4, 2025Use of Device Problem; Use of Device Problem

  CLINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6) (B)(4). IT WAS REPORTED THAT ON (B)(6) 2024, A 14MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THERE WAS NO DIFFICULTY EXPERIENCED USING THE 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. POST--PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD A RIGHT ARTERIOVENOUS FISTULA AT THE ACCESS SITE OF THE DELIVERY SYSTEM. ON (B)(6) 2024, AN ULTRASOUND WAS PERFORMED AND REVEALED PERSISTENCE OF THE RIGHT ARTERIOVENOUS FISTULA. THE DECISION WAS MADE TO PERFORM A SURGICAL LIGATION OF THE RIGHT ARTERIOVENOUS FISTULA. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE CAUSE OF THE PATIENT'S RIGHT ARTERIOVENOUS FISTULA IS UNCERTAIN. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT.

  Patient problems: Vascular Dissection

  MAUDE report 21518116 ↗
• InjuryOct 11, 2023Retraction Problem; Material Split, Cut or Torn; Retraction Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2023, A 11MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A AMPLATZER TREVISIO DELIVERY SYSTEM. DURING IMPLANTATION, THE OCCLUDER COULD NOT BE RECAPTURED BY THE DELIVERY SHEATH. TWO OTHER DELIVERY SYSTEMS WERE USED TO ATTEMPT RECAPTURE BUT FAILED. THE PATIENT WAS THEN SENT TO SURGERY TO HAVE THE OCCLUDER EXPLANTED AND THE ASD REPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914002 ↗
• InjuryOct 11, 2023Retraction Problem; Material Split, Cut or Torn; Retraction Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2023, A 11MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A AMPLATZER TREVISIO DELIVERY SYSTEM. DURING IMPLANTATION, THE OCCLUDER COULD NOT BE RECAPTURED BY THE DELIVERY SHEATH. TWO OTHER DELIVERY SYSTEMS WERE USED TO ATTEMPT RECAPTURE BUT FAILED. THE PATIENT WAS THEN SENT TO SURGERY TO HAVE THE OCCLUDER EXPLANTED AND THE ASD REPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913816 ↗
• InjuryOct 11, 2023Retraction Problem; Material Split, Cut or Torn; Retraction Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2023, A 11MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A AMPLATZER TREVISIO DELIVERY SYSTEM. DURING IMPLANTATION, THE OCCLUDER COULD NOT BE RECAPTURED BY THE DELIVERY SHEATH. TWO OTHER DELIVERY SYSTEMS WERE USED TO ATTEMPT RECAPTURE BUT FAILED. THE PATIENT WAS THEN SENT TO SURGERY TO HAVE THE OCCLUDER EXPLANTED AND THE ASD REPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913733 ↗