Amplatzer™ 9-ASD-MF-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 00811806010304), received between Aug 27, 2018 and Sep 29, 2026 — classified as 32 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (88 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 25 most recent of 149 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941058 ↗
• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903203 ↗
• MalfunctionSep 23, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862998 ↗
• InjuryAug 28, 2026Insufficient Device Problem Information

  It was reported that on an unknown date, a 30mm Amplatzer Cribriform Occluder was chosen for implant. Subsequently, the patient reported experiencing low blood oxygen levels, bubbles in the bloodstream, blood in the urine, blue urine, and loss of consciousness.

  Patient problems: Air Embolism; Hypoxia; Syncope/Fainting

  MAUDE report 50505828 ↗
• MalfunctionMar 31, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30MM AMPLATZER CRIBRIFORM OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 9F AMPLATZER TREVISIO DELIVERY SYSTEM. THE PATIENT PRESENTED WITH A PATENT FORAMEN OVALE (PFO) AND AN ATRIAL SEPTAL DEFECT (ASD) AND WAS BEING TREATED FOR PFO. BASED ON THE LOCATION OF THE ASD, THE PHYSICIAN SELECTED THE 30MM CRIBRIFORM DEVICE WITH THE INTENT TO COVER BOTH DEFECTS. DURING DEPLOYMENT, THE LEFT ATRIAL DISC DEMONSTRATED A BULBOUS APPEARANCE AND DID NOT LAY FLAT AGAINST THE SEPTUM. THE DEVICE WAS RECAPTURED AND REDEPLOYED; HOWEVER, THE SAME OUTCOME WAS OBSERVED. THE OCCLUDER WAS THEN REMOVED FROM THE BODY, RE-PREPARED, AND REDEPLOYED AGAIN, WITH THE SAME RESULT NOTED. FOLLOWING THESE UNSUCCESSFUL ATTEMPTS, THE DECISION WAS MADE TO DISCONTINUE USE OF THE 30MM CRIBRIFORM OCCLUDER AND INSTEAD IMPLANT A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER, WHICH WAS SUCCESSFULLY DEPLOYED WITHOUT COMPLICATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24738090 ↗
• MalfunctionMar 20, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT USING AN AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTING, IT WAS NOTED THAT THE OCCLUDER DID NOT CONFORM TO ITS DESIRED SHAPE BUT TOOK FORM OF TULIP SHAPE AND DID NOT SIT WELL AGAINST THE WALL. THE DEFORMED DEVICE WAS RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A 35MM AMPLATZER CRIBRIFORM. 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 24651794 ↗
• MalfunctionFeb 27, 2026Difficult to Fold, Unfold or Collapse; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN FOR A PATENT FORAMEN OVALE (PFO) CLOSURE PROCEDURE USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEPLOYMENT, A HEAVY BULGING ON THE LEFT ATRIAL DISC WAS NOTED. THE DEFORMED DEVICE EVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS REPORT OF INTERACTION WITH CARDIAC STRUCTURES WAS NOTED DURING DEPLOYMENT. THERE WAS NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. A NEW 30MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469548 ↗
• MalfunctionFeb 27, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469365 ↗
• MalfunctionJan 12, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT USING AN9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE WHILE DEPLOYING, IT WAS OBSERVED THAT THE OCCLUDER DID NOT CONFORM TO ITS DESIRED SHAPE AND TOOK FORM OF A "TEACUP". THE PROCEDURE WAS COMPLETED USING A NEW 30MM AMPLATZER CRIBRIFORM. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE 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 24036094 ↗
• MalfunctionDec 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23833357 ↗
• MalfunctionDec 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23784435 ↗
• MalfunctionDec 5, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728948 ↗
• MalfunctionDec 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT USING 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, AFTER THE DEVICE WAS POSITIONED IN THE PATIENT¿S ATRIUM, AN INVERSION WAS OBSERVED ON THE LEFT SIDE, PRESENTING A CONCAVE SHAPE. THE DEVICE WAS PLACED IN WARM SALINE SOLUTION MULTIPLE TIMES IN AN ATTEMPT TO CORRECT THE ISSUE; HOWEVER, IT INVERTED AGAIN UPON REPOSITIONING. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 30MM AMPLATZER CRIBRIFORM. 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 23687812 ↗
• MalfunctionNov 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622568 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_1032 - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE OCCLUDER WAS SUCCESSFULLY IMPLANTED. AFTER THE PROCEDURE, AN ATRIAL TACHYCARDIA INTERMITTENT WAS NOTED IN THE PATIENT AND 5MG/D BISOPROLOL WAS ADMINISTRATED.

  Patient problems: Tachycardia

  MAUDE report 23617214 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE IN (B)(6) 2010, AN UNKNOWN AMPLATZER MULTI-FENESTRATED CRIBRIFORM WAS IMPLANTED. IT WAS NOTED THAT ANOTHER HOLE HAD OPENED AT THE SITE OF THE IMPLANT. NO ADDITIONAL DATES OR CLINICAL DETAILS WERE PROVIDED.

  Patient problems: Atrial Fibrillation; Perforation

  MAUDE report 23560717 ↗
• MalfunctionOct 30, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER CRIBRIFORM DEVICE WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, THE PREPARATION OF THE DEVICE WAS NORMAL. HOWEVER, THE RIGHT ATRIAL (RA) DISC APPEARED SLIGHTLY BULBOUS WHEN THE PREP WAS REPEATED. THE TEAM DECIDED TO PROCEED, THINKING THAT WITH TEMPERATURE CHANGE AND DELIVERY SHEATH AGAINST THE DISC IT MAY CHANGE. THE ANATOMY WAS CHALLENGING DUE TO AN ANEURYSMAL PFO SEPTUM. WHEN THE LEFT ATRIAL (LA) DISC WAS RELEASED, IT INITIALLY APPEARED BULBOUS. AFTER RECAPTURING AND REPOSITIONING THE LA DISC, IT FORMED NATURALLY. LATER, UPON RELEASING AND POSITIONING THE RA DISC AT THE SEPTUM, IT CAUSED THE LA DISC TO DEFORM. THIS OCCURRED MULTIPLE TIMES. THE DEVICE WAS PLACED IN A NORMAL POSITION BUT IT WAS NOT RELEASED FROM THE CABLE AS THE DEVICE WAS DEFORMED. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23431440 ↗
• MalfunctionOct 10, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE FORMED A BULBOUS SHAPE WHILE DEPLOYING INTO THE RIGHT ATRIUM. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. IT WAS NOTED THAT THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 35MM AMPLATZER CRIBRIFORM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23271602 ↗
• MalfunctionOct 10, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER CRIBIFORM WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER DID NOT TAKE ITS DESIRED SHAPE AND TOOK FORM OF A BULBOUS SHAPE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW 30MM AMPLATZER CRIBRIFORM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OBSERVED DURING THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23263182 ↗
• MalfunctionSep 23, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER CRIBRIFORM MULTI-FENESTRATED SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 10F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER DID NOT CONFORM INTO THE DESIRED SHAPE. IT WAS NOTED THAT IT TOOK A "BULGED" SHAPE. THE PROCEDURE WAS COMPLETED USING NEW 30MM AMPLATZER CRIBRIFORM. IT WAS ALSO NOTED THAT THERE WERE INTERACTIONS WITH THE INTER ATRIAL SEPTUM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23126413 ↗
• MalfunctionSep 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025, A 25MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM TO TREAT A MULTI-FENESTRATED ATRIAL SEPTAL DEFECT. DURING IMPLANT THE OCCLUDER TOOK ON A BULBOUS SHAPE. THE OCCLUDER WAS RE-CAPTURED AND RE-DEPLOYED, HOWEVER THE OCCLUDER THE BULBOUS SHAPE REMAINED. THE OCCLUDER WAS REMOVED FROM THE PATIENT. THE OCCLUDER WAS PUSHED OUT OF THE LOADER MULTIPLE TIMES HOWEVER THE BULBOUS SHAPE STILL REMAINED. A NEW 30MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS SELECTED FOR IMPLANT. DURING IMPLANT THE SECOND OCCLUDER ALSO TOOK ON A BULBOUS SHAPE. THE OCCLUDER WAS REMOVED FROM THE PATIENT. THE DEVICES WERE NEVER RELEASED FROM THE DELIVERY CABLE. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. 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 22964806 ↗
• MalfunctionAug 26, 2025Difficult to Fold, Unfold or Collapse; Off-Label Use; Difficult to Fold, Unfold or Collapse; Off-Label Use

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898623 ↗
• MalfunctionJul 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN FOR IATROGENIC ATRIAL SEPTAL DEFECT (ASD) USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE WAS VERY BULBUS WHEN DELIVERED ON THE BOTH THE LEFT ATRIAL (LA) AND RIGHT ATRIAL (RA) AND IT WASN'T SITTING FLAT. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. A NEW 30MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591565 ↗
• MalfunctionMay 23, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 30MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM WAS SELECTED FOR IMPLANT USING AN AMPLATZER TREVISIO DELIVERY SYSTEM. DURING IMPLANT IT WAS NOTED THAT THE BOWING OF THE LEFT ATRIAL DISC OF THE DEVICE WOULD NOT FLATTEN OUT WHEN DEPLOYED AND FORMED A CUPPING SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 25MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. 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 22080220 ↗
• MalfunctionApr 18, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHILE DEPLOYING THE DEVICE, IT PRESENTED IN A BULBOUS INFORMATION. THE DEVICE WASN'T IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867069 ↗