Amplatzer PiccoloRecalls & reported problems across all models

We found 10 models of Amplatzer Piccolo by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 183 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2019 and Sep 25, 2026 — classified as 18 deaths, 143 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (118 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 Piccolo problems

Amplatzer Piccolo models

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

• Amplatzer Piccolo™ 9-PDAP-05-04-L

  OCCLUDER, PATENT DUCTUS, ARTERIOSUS
  1 death45 reports
• Amplatzer Piccolo™ 9-PDAP-05-02-L

  OCCLUDER, PATENT DUCTUS, ARTERIOSUS
  4 deaths43 reports
• Amplatzer Piccolo™ 9-PDAP-04-02-L

  OCCLUDER, PATENT DUCTUS, ARTERIOSUS
  7 deaths31 reports
• Amplatzer Piccolo™ 9-PDAP-04-04-L

  OCCLUDER, PATENT DUCTUS, ARTERIOSUS
  3 deaths24 reports
• Amplatzer Piccolo™ 9-PDAP-05-06-L

  OCCLUDER, PATENT DUCTUS, ARTERIOSUS
  12 reports
• Amplatzer Piccolo™ 9-PDAP-03-02-L

  OCCLUDER, PATENT DUCTUS, ARTERIOSUS
  2 deaths11 reports
• Amplatzer Piccolo™ 9-PDAP-03-04-L

  OCCLUDER, PATENT DUCTUS, ARTERIOSUS
  1 death11 reports
• Amplatzer Piccolo™ 9-PDAP-04-06-L

  OCCLUDER, PATENT DUCTUS, ARTERIOSUS
  3 reports
• Amplatzer Piccolo™ 9-PDS-04F-045

  Catheter, percutaneous
  2 reports
• Amplatzer Piccolo™ 9-PDAP-03-06-L

  OCCLUDER, PATENT DUCTUS, ARTERIOSUS
  1 report

Recent Amplatzer Piccolo adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 4F Amplatzer Piccolo Delivery System was chosen for a Patent Ductus Arteriosus (PDA) closure procedure on a 3week old, 1000grams premature infant. During procedure, the right femoral vein access was achieved in the usual manner and a 4F access sheath was placed. A non-Abbott wire and Piccolo Delivery System (PDS) combination was advanced up the inferior vena cava (IVC), across the tricuspid valve towards the right ventricular outflow tract (RVOT) and into the pulmonary artery(PA). The non-Abbott wire was advanced in an attempt to engage the PDA, but would not track down the descending aorta. The non-Abbott wire was then exchanged for an another non-Abbott glide wire which took an unusual course and appeared to be in the pericardial space. The baby was stable at this point. The glide-wire and PDS was then withdrawn back into the IVC at which point the baby become hypotensive and tachycardic. A transthoracic echocardiogram (TTE) assessment was done and revealed a rapidly accumulating 5mm circumferential pericardial effusion. The glide wire and PDS was then removed from the body and a pericardiocentesis was performed. A 8ccs of blood was removed

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Tachycardia

  MAUDE report 50897010 ↗
• InjurySep 23, 2026Migration or Expulsion of Device

  It was reported on an unknown date a 3mm x 4mm Amplatzer Piccolo Occluder was selected for implant using a 4F Amplatzer Piccolo Delivery System. During device preparation it was noted that the vise would not lock down on the piccolo delivery system wire. The occluder was implanted. Post-implant the device embolized. An attempt was made to snare the occluder but was unsuccessful.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872883 ↗
• InjurySep 18, 2026Migration or Expulsion of Device

  It was reported on (b)(6) 2026 a 3mm x 2mm Amplatzer Piccolo Occluder was selected for implant. The patient had a ductus with a minimal diameter of 1.4mm and length of 7mm. Transthoracic echocardiogram (TTE) and fluoroscopy were used during the procedure. Upon fully releasing the occluder from the delivery cable, the device embolized into the pulmonary artery. The patient experienced moderate tricuspid regurgitation (TR). The device was snared and removed from the patient, which resolved the TR. A 4mm x 2mm Amplatzer Piccolo Occluder was implanted. The patient status was stable. The physician believed the compliant duct and steep angle of the patent ductus arteriosus takeoff caused the embolization.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50821207 ↗
• MalfunctionMar 23, 2026Air/Gas in Device

  IT WAS REPORTED ON 11 FEBRUARY AN AMPLATZER PICCOLO WAS SELECTED FOR IMPLANT USING A 4F AMPLATZER PICCOLO DELIVERY SYSTEM. ALL STEPS WERE PERFORMED PER INSTRUCTIONS FOR USE (IFU). WHILST INSERTING THE LOADER INTO THE TUOHY CONNECTED TO THE CATHETER WITHIN THE PATIENT, PRIOR TO INSERTING THE DELIVERY SYSTEM INTO THE FEMORAL VEIN, IT WAS NOTED THAT AIR CONTINUOUSLY OBSERVED IN THE HEMOSTATIC VALVE OF THE LOADER. A WET-TO-WET CONNECTION WAS CORRECTLY ESTABLISHED. BACKFLOW WAS USED TO REMOVE AIR BUBBLES. AN ATTEMPT WAS MADE TO DISCONNECT THE COMPONENTS OF THE DELIVERY SYSTEM AND RE-DO DEVICE PREPARATION. THE DEVICE WAS REPLACED WITH A NEW 16MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER. THE SAME DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663505 ↗
• MalfunctionMar 20, 2026Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2026, A 04-04 AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 4F PICCOLO DELIVERY SYSTEM PRIOR TO IMPLANTATION, THE DEVICE WAS CHECKED TO CONFIRM THAT IT WAS PROPERLY SECURED TO THE DELIVERY CABLE. DURING THE PROCEDURE, AS THE PHYSICIAN ADVANCED THE DEVICE INTO THE PATIENT¿S AORTA SO THAT ONLY THE AORTIC DISC WAS WITHIN THE VESSEL AND BEFORE IT WAS RELEASED FROM THE SHEATH, THE DEVICE WAS OBSERVED TO HAVE BECOME DETACHED FROM THE DELIVERY CABLE. DESPITE THIS, THE PHYSICIAN WAS ABLE TO ACCURATELY UNSHEATH THE DEVICE AND POSITION IT WITHIN THE DUCT AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651793 ↗
• MalfunctionJan 30, 2026Premature Separation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223993 ↗
• InjuryJan 23, 2026Migration or Expulsion of Device; Patient Device Interaction Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24169053 ↗
• InjuryJan 16, 2026Migration or Expulsion of Device; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (b)(6) 2025, A 4X4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F AMPLATZER TVLP CATHETER IN A PATENT DUCTUS ARTERIOSUS (PDA) OCCLUSION PROCEDURE. THE DIMENSIONS OF THE DEFECT WERE MEASURED AS 4.1 MM AT THE AORTA, 2.7 MM AT THE PULMONARY END, AND 7.5 MM IN LENGTH. THE SIZING OF THE DEVICE WAS DETERMINED USING ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY. DURING THE PROCEDURE, ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY WERE UTILIZED AS IMAGING MODALITIES. AT THE TIME OF RELEASE, THE TEAM ENCOUNTERED DIFFICULTY, NOTING THAT THE DEVICE APPEARED TO BE TIGHTLY ATTACHED TO THE SCREW, WHICH RESULTED IN THE DEVICE TWISTING ALONG ITS AXIS. CONSEQUENTLY, ITS POSITION WAS ALTERED WITHIN THE HEART, LEADING TO EMBOLIZATION AFTER RELEASE. THE MIGRATION/EMBOLIZATION WAS IDENTIFIED THROUGH ANGIOGRAPHY. THE DEVICE COMPLETELY DISLODGED FROM THE IMPLANT SITE. THE IMPLANTER BELIEVES THE CAUSE OF EMBOLIZATION WAS DIFFICULTY RELEASING THE PROSTHESIS, WITH TWISTING OF THE PROSTHESIS WITHIN ITS OWN SHAFT. A STABILITY CHECK WAS PERFORMED, AND NO LEAK WAS DETECTED AROUND THE LOBE OF THE DEVICE DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY RHYTHM C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098825 ↗
• InjuryJan 12, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4 MM X 4 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING THE PROCEDURE, UPON RELEASING THE DEVICE, IT WAS NOTED THAT THE DEVICE EMBOLIZED INTO THE MAIN PULMONARY ARTERY. THE DEVICE WAS COMPLETED USING A 5MM X 2MM AMPLATZER PICCOLO OCCLUDER. 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 24038244 ↗
• InjuryJan 12, 2026Fracture; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 3 MM X 6 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM. DURING THE PROCEDURE, THE CABLE BROKE INSIDE THE PATIENT WHILE THE PICCOLO PROSTHESIS WAS PARTIALLY UNSCREWED. THE OCCLUDER GOT SEPARATED FROM THE DELIVERY CABLE BEFORE IT WAS DEPLOYED. THE CLINICAL TEAM WAS UNCERTAIN HOW THIS OCCURRED. THE DEVICES WERE EVENTUALLY RETRIEVED WITH DIFFICULTY USING SNARES. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. 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 24036224 ↗
• MalfunctionJan 2, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 5 MM X 6 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE CONFORMED INTO A COBRA-LIKE DEFORMATION. THE PHYSICIAN HAS SCHEDULED FOR AN ELECTIVE SURGERY. 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 23950591 ↗
• InjuryJan 2, 2026Migration or Expulsion of Device; Separation Problem

  IT WAS REPORTED (B)(6) 2025, A 4X4 AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F TVLP CATHETER. DURING THE PROCEDURE, THE DEFECT WAS MEASURED TO BE 4.1 MM AT THE AORTA, 2.7 MM AT THE PULMONARY END, AND 7.5 MM IN LENGTH. THE SIZING OF THE DEVICE WAS DETERMINED USING ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY, WHICH WERE ALSO THE IMAGING MODALITIES UTILIZED DURING THE PROCEDURE. THE MIGRATION OF THE DEVICE WAS IDENTIFIED THROUGH ANGIOGRAPHY. IT WAS NOTED THAT THE DEVICE COMPLETELY DISLODGED FROM THE INTENDED IMPLANT SITE. ACCORDING TO THE IMPLANTER, THE CAUSE OF EMBOLIZATION WAS ATTRIBUTED TO DIFFICULTY IN RELEASING THE PROSTHESIS, WITH TWISTING OF THE PROSTHESIS WITHIN ITS OWN AXIS. THE EMBOLIZATION WAS RECOGNIZED DURING THE PROCEDURE. THERE WERE NO RHYTHM CHANGES AND NO LEAK DETECTED AROUND THE LOBE OF THE DEVICE DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SIGNS OR SYMPTOMS SUCH AS ARRHYTHMIA, VALVE INTERACTION, OR HEMODYNAMIC INSTABILITY. THERE WAS NO DIFFICULTY WITH IMPLANTING THE DEVICE, SUCH AS MULTIPLE RECAPTURES OR REPOSITIONING. TO ADDRESS THE EMBOLIZATION, A PERCUTANEOUS RECAPTURE ATTEMPT WITH A SNARE WAS PERFORMED. THE EMBOLIZED D

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950589 ↗
• InjuryDec 23, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 4F AMPLATZER TVLP DELIVERY SYSTEM. THE DIMENSIONS OF THE DEFECT WERE 4.1 MM (AORTA), 2.7 MM (PULMONARY), AND 7.5 MM IN LENGTH. THE SIZING OF THE DEVICE WAS DETERMINED BY ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY. DURING THE PROCEDURE IT WAS NOTED THAT THE OCCLUDER EMBOLIZED. ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY WERE USED DURING THE PROCEDURE, AND ANGIOGRAPHY IDENTIFIED THE MIGRATION/EMBOLIZATION. THE IMPLANTER BELIEVES THE CAUSE OF EMBOLIZATION WAS DIFFICULTY IN RELEASING THE PROSTHESIS, WITH TWISTING OF THE PROSTHESIS WITHIN ITS OWN AXIS. IT BECAME KNOWN THAT THE DEVICE HAD EMBOLIZED DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE A RHYTHM CHANGE, AND NO LEAK WAS DETECTED AROUND THE LOBE OF THE DEVICE. AN ATTEMPTED PERCUTANEOUS RETRIEVAL WITH SNARE WAS PERFORMED TO ADDRESS THE EMBOLIZATION. THE EMBOLIZED DEVICE CAUSED A PARTIAL OR COMPLETE OBSTRUCTION OF BLOOD FLOW AND TRAVELED TO THE DISTAL BRANCH OF THE RIGHT PULMONARY ARTERY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881544 ↗
• InjuryDec 8, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 5 MM X 4 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE PROCEDURE USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE PATIENT'S GESTATIONAL AGE WAS 22.5 WEEKS. THE PDA MINIMAL DIAMETER WAS 3.6MM, THE PDA DIAMETER AT AORTIC AMPULLA WAS 4MM AND PDA LENGTH WAS 10MM. DURING PROCEDURE, THE TEAM BELIEVED THE AORTIC (AO) DISC MAY BE PROTRUDING INTO THE AO SLIGHTLY SO THE DEVICE WAS REMOVED WITHOUT BEING RELEASED FROM CABLE. A NEW 5 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN, PLACED WITH NO ISSUE AND RELEASED. IMMEDIATELY AFTER RELEASE, THE DEVICE WAS NOTED TO MIGRATE TOWARDS THE PULMONARY ARTERY (PA) WITH THE PA DISC AND THE CENTER LOBE PROTRUDING INTO THE PA. ALTHOUGH THERE WAS STILL FLOW INTO THE LEFT PULMONARY ARTERY (LPA), IT WAS DETERMINED THE DEVICE WAS UNSTABLE AND BLOCKING TOO MUCH FLOW SO THE DEVICE WAS RETRIEVED VIA PERCUTANEOUS RETRIEVAL AND REMOVED WITHOUT INCIDENCE. THE FIRST 5 MM X 4 MM AMPLATZER PICCOLO OCCLUDER WAS PLACED AGAIN AND RELEASED WITHOUT INCIDENCE OR OBSTRUCTION OF THE AO OR PA. THE IMPLANTER BELIEVE WAS THE CAUSE OF EMBOLIZATION WAS INCORRECT SIZING. THE PATIENT REMAINED STABL

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 23745802 ↗
• MalfunctionDec 5, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 04-04MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING, THE PHYSICIAN NOTICED THAT THE DEVICE WAS NOT CONFORMING TO ITS DESIRED SHAPE. THEREFORE, THE DEFORMED DEVICE WAS RETRIEVED BACK. 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 WAS REFERRED FOR SURGERY TO COMPLETE THE PROCEDURE. 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 23731473 ↗

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