Amplatzer™ 9-SB-018Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00811806011516), received between Feb 25, 2020 and Mar 20, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 16, 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.

• MalfunctionMar 20, 2026Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 18MM AMPLATZER SIZING BALLOON II WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) PROCEDURE. DOING PROCEDURE, THEY WENT TO USE A SIZING BALLOON AND THE BALLOON RUPTURED AT THE TIP OF THE BALLOON. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648347 ↗
• MalfunctionFeb 20, 2026Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2026, A 18MM AMPLATZER SIZING BALLOON II WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE. DURING ASD PROCEDURE, THE SIZING BALLOON WAS EXPLODED WHILE INFLATION. A NEW 18MM AMPLATZER SIZING BALLOON II WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400791 ↗
• MalfunctionSep 5, 2025Deflation Problem; Fracture; Deflation Problem; Fracture

  IT WAS REPORTED ON (B)(6) 2025 A 14 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. ALL DEVICES WERE PREPARED PER INSTRUCTIONS FOR USE (IFU). SIZING WAS DONE WITH AN 18 MM AMPLATZER SIZING BALLOON II. WHILE DEFLATING THE SIZING BALLOON, AIR COULD NOT BE RELEASED. UPON INSPECTION THE HUB OF THE BALLOON APPEARED TO BE CRACKED. A NEW SIZING BALLOON WAS USED TO COMPLETE SIZING. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS RESISTANCE WHEN INSERTING THE DELIVERY SYSTEM INTO THE PATIENT AND ADVANCING THE DELIVERY SYSTEM THROUGH THE PATIENT ANATOMY. THE OCCLUDER COULD NOT BE ADVANCED THROUGH THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REPLACED WITH A NEW 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982575 ↗
• MalfunctionDec 16, 2024Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN 18MM AMPLATZER SIZING BALLOON II WAS SELECTED FOR A PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS DIFFICULTY INSERTING THE BALLOON INTO THE PATIENT. AFTER INSERTION, IT WAS OBSERVED THAT THE TIP OF THE BALLOON SPLIT AND COULD NOT ADVANCE THROUGH THE PATENT FORAMEN OVALE (PFO). THE SPLIT TIP WAS NOTED AFTER THE BALLOON MADE CONTACT WITH THE GUIDEWIRE. THE DEVICE WAS REMOVED FROM THE PATIENT. A 25MM SIZED DEVICE WAS CHOSEN THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) MEASUREMENTS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20942788 ↗
• InjuryFeb 25, 2020Human-Device Interface Problem; Human-Device Interface Problem

  ON (B)(6) 2020, A 12/10MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM (DS) TO CLOSE A FISTULA, AWARE THIS IS AN OFF-LABEL USE. HOWEVER, THE OCCLUDER WAS NOT RELEASED BECAUSE IT DID NOT REMAIN SEATED WHEN TUGGED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN DECIDED TO RE-MEASURE THE FISTULA WITH AN 18MM AMPLATZER SIZING BALLOON. THE FISTULA MEASURED ABOUT 14MM AND THE SIZING BALLOON WAS DECOMPRESSED. HOWEVER, THE PATIENT BECAME SEVERELY HEMODYNAMICALLY COMPROMISED AND HAD REDUCED RIGHT VENTRICLE COMPRESSION. THE SIZING BALLOON WAS RE-INSERTED AND RE-INFLATED TO BLOCK THE SHUNT AND THE PATIENT REGAINED HEMODYNAMIC STABILITY. A 16MM AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TORQVUE DS TO CLOSE THE FISTULA; THE PHYSICIAN IS AWARE THIS IS OFF-LABEL USE. THERE WAS SIGNIFICANT RESISTANCE WHEN INSERTING THE DELIVERY SHEATH. THE 16MM OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE END OF THE PROCEDURE AND MOVED TO THE CCU FOR OBSERVATION. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Heart Failure

  MAUDE report 9751489 ↗