Amplatzer Piccolo™ 9-PDAP-03-04-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05415067030986), received between Nov 25, 2019 and Sep 23, 2026 — classified as 1 death, 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (8 reports).

5 other recalls cover devices cleared under the same FDA submission (P020024); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

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

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24169053 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Unspecified Infection

  MAUDE report 22926485 ↗
• InjuryFeb 10, 2025Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A 3MM X 4MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2025 FOR A 4 WEEK OLD PATIENT WITH A WEIGHT OF 900 GRAMS, A MINIMAL DUCTUS DIAMETER OF 1.9MM AND A DUCTAL LENGTH OF 9MM. SIZING WAS DETERMINED THROUGH FLUOROSCOPIC ANGIOGRAM. DURING THE PROCEDURE, UPON RELEASE OF THE OCCLUDER FROM THE DELIVERY CABLE, THE OCCLUDER EMBOLIZED TO THE LEFT PULMONARY ARTERY. THE OCCLUDER WAS SNARED AND REMOVED FROM THE PATIENT. A NEW 4MM X 2MM AMPLATZER PICCOLO OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THE USER BELIEVE A DUCTAL SPASM CAUSED THE OCCLUDER TO EMBOLIZE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345422 ↗
• InjuryDec 5, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON 07 NOVEMBER 2024, A 3-4MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT WITH A 4F AMPLATZER TORQVUE LP DELIVERY SHEATH FOR PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE IN A 3-WEEK-OLD, 1017G PATIENT. THE PDA MINIMAL DIAMETER MEASURED 1.7MM. DURING PROCEDURE, THE PHYSICIAN CONFIRMED PLACEMENT OF THE 3-4MM AMPLATZER PICCOLO WAS IN THE CORRECT POSITION WITH NO OBSTRUCTION TO THE AORTA AND LEFT PULMONARY ARTERY, THE DEVICE WAS STABLE, AND THERE WAS NO CLINICALLY SIGNIFICANT RESIDUAL SHUNT. AFTER THE PICCOLO OCCLUDER WAS DEPLOYED INTRADUCTALLY, IT EMBOLIZED INTO THE PULMONARY ARTERY. A DECISION WAS MADE TO RETRIEVE AND EXPLANT THE DEVICE VIA TRANSCATHETER SNARE. A REPLACEMENT 4-2MM AMPLATZER PICCOLO DEVICE WAS IMPLANTED WITH THE SAME 4F AMPLATZER TORQVUE LP DELIVERY SHEATH. IT WAS THEN REPORTED CATHETER INFECTION WAS SUSPECTED AND ANTIBIOTIC TREATMENT WAS ADMINISTERED. THERE WAS NO REPORT OF ANY BENDS/KINKS OBSERVED IN THE DELIVERY SHEATH. THERE WAS NO REPORT OF ANY CONTACT WITH INTRACARDIAC TISSUE DURING OCCLUDER DEPLOYMENT. THE PATIENT'S STATUS WAS REPORTED AS UNSTABLE BUT NOT RELATED TO THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20853263 ↗
• DeathOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 3-4MM AMPLATZER PICCOLO OCCLUDER WAS IMPLANTED. THE PDA MINIMAL DIAMETER WAS 3.1MM BY ECHO. THE PDA DIAMETER AT THE AORTIC AMPULLA WAS 3.5MM. THE PDA LENGTH WAS 9MM. THE OCCLUDER WAS PLACED INTRADUCTAL AND THE PULSE CHECKLIST WAS USED. THE PRE-, INTRA-, AND IMMEDIATE POST-PROCEDURE COURSE WAS UNEVENTFUL. ON (B)(6) 2024, BLOOD CULTURES REVEALED PSEUDOMONAS AERUGINOSA. ON (B)(6) 2024, THE PATIENT PASSED AWAY (12 DAYS POST-IMPLANT) DUE TO SEPTIC SHOCK SECONDARY TO PSEUDOMONAS BACTEREMIA. THE PATIENT'S GESTATIONAL AGE WAS 27 4/7 WEEKS. THE PHYSICIAN DOES NOT SUSPECT THE PATIENT PASSING AS RELATED TO THE PICCOLO OCCLUDER. THE LAST ECHOCARDIOGRAM PRIOR TO DEATH SHOWED THE DEVICE IN GOOD POSITION WITH NO RESIDUAL FLOW AND NO OBSTRUCTION TO THE FLOW IN THE AORTA OR THE LEFT PULMONARY ARTERY.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 20428862 ↗
• InjuryApr 23, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166792 ↗
• MalfunctionApr 17, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 3 MM X 4 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PROCEDURE USING A 14F AMPLATZER TORQVUE LOW PROFILE CATHETER FOR A 4 WEEK, 0.68 KG PATIENT. DURING PROCEDURE, WHILE RELEASING THE DEVICE FROM THE DELIVERY CABLE, THE DEVICE PIN BECAME LODGED INSIDE THE END OF THE DELIVERY CATHETER. THE PHYSICIAN USED A NON-ABBOTT WIRE TO DISLODGE DEVICE PIN FROM THE CATHETER, AND THE WIRE PUSHED PAST DEVICE INSIDE PATENT DUCTUS ARTERIOSUS (PDA). WHEN REMOVING THE WIRE, DEVICE MOVED ANTERIOR LEAVING MIDDLE LOBE AND PULMONARY ARTERY (PA) DISC INSIDE PA WITH AORTA DISC STILL INSIDE PDA. THE PDA WAS COMPLETELY CLOSED BUT MILD LEFT PULMONARY ARTERY (LPA) STENOSIS WAS NOTED. THE CAUSE FOR PIN DISLODGE WAS THAT THE DELIVERY CATHETER WAS TOO CLOSE TO THE DEVICE PIN DURING RELEASE. THE PATIENT'S VITALS REMAINED STABLE WITH NO CONSEQUENCES. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127617 ↗
• InjuryNov 8, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 3M X 4MM AMPLATZER PICCOLO OCCLUDER, LOT 8462779, WAS CHOSEN FOR IMPLANT IN A 1.2 KG PATIENT WITH UNKNOWN PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS. THE DEVICE WAS PLACED WITHIN THE PDA USING AN ABBOTT DELIVERY SYSTEM, AND THE OCCLUDER WAS RELEASED IN THE INTRADUCTAL PLACEMENT. FOLLOWING RELEASE, THE DEVICE EMBOLIZED INTO THE LEFT PULMONARY ARTERY DURING PROCEDURE BEFORE LEAVING THE CATHETERIZATION LABORATORY, AND THE DEVICE POSITION WAS DETERMINED BY FLUOROSCOPIC EVALUATION. THE EMBOLIZED OCCLUDER WAS EMERGENTLY SNARED AND REMOVED. A 4MM X 2MM AMPLATZER PICCOLO OCCLUDER, LOT 8421936, WAS THEN SUCCESSFULLY IMPLANTED. FOLLOWING THE PROCEDURE, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND THERE WAS MODERATE TRICUSPID REGURGITATION NOTED, TO BE MONITORED. THE PHYSICIAN REPORTED THAT THE CAUSE OF EMBOLIZATION IS DUE TO DEVICE UNDER SIZING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 15752765 ↗
• InjuryAug 21, 2020Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  ON (B)(6) 2020, A 3/4 AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A (B)(6) DAY OLD, (B)(6) KG PATIENT WITH PATENT DUCTUS ARTERIOSUS DIMENSIONS OF: MINIMAL DIAMETER OF 1.5MM, LENGTH OF 13.3MM, AND A DIAMETER AT AORTIC AMPULLA OF 3.3MM. THE DEVICE WAS PLACED EXTRADUCTAL, BUT WAS DETERMINED TO BE MIS-SIZED. THE 3/4 AMPLATZER PICCOLO OCCLUDER WAS RELEASED AND SECONDS LATER IT EMBOLIZED INTO THE PATIENT'S PULMONARY ARTERY. THE DEVICE WAS RETRIEVED USING A TRANSCATHETER SNARE AND EXCHANGED FOR A 4/4 AMPLATZER PICCOLO OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS CURRENTLY STABLE, HEALTHY AND DISCHARGED.

  Patient problems: Embolism

  MAUDE report 10440106 ↗
• InjuryNov 25, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2019, A 3-4MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A 2KG PATIENT WITH A PDA (MINIMAL DIAMETER=2.76MM, DIAMETER AT AORTIC AMPULLA=4.14MM AND A LENGTH=13.88MM). THE DEVICE WAS PREPARED FOR IMPLANTED AND DEPLOYED INTRADUCTAL. THE DELIVERY CATHETER WAS NOTED TO BE ABUTTING THE DEVICE WHILE THE DELIVERY CABLE WAS UNSCREWED. THE DEVICE WAS RELEASED FROM THE DELIVERY CABLE WITHOUT DIFFICULTY; HOWEVER, THE END SCREW WAS OBSERVED TO BE TOUCHING THE DELIVERY CATHETER. WHILE DRAWING BACK THE DELIVERY CATHETER WITH FORCE, THE DEVICE BECAME UNSTABLE AND EMBOLIZED TO THE RIGHT PULMONARY ARTERY. THE DEVICE WAS RETRIEVED USING A 3.5F 4-8MM "N SNARE." A 4-2MM AMPLATZER PICCOLO OCCLUDER (LOT NUMBER: 7167698) WAS ATTEMPTED FOR IMPLANT BUT WAS EXCHANGED FOR A 4-4 AMPLATZER PICCOLO OCCLUDER TO ENSURE STABILITY OF THE DEVICE. THE 4-4MM AMPLATZER PICCOLO OCCLUDER (LOT NUMBER: 6800257) WAS SUCCESSFULLY IMPLANTED AND THE PATIENT IS REPORTED TO BE STABLE. PER THE SITE, THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND NO EFFUSION, TRICUSPID OR PULMONARY INSUFFICIENCY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9372950 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020024. One submission often covers many models, so check the product and lot details in each record.

• Z-2192-2008 · Apr 25, 2008 · Terminated
  AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle Curve, 80 Usable Length (cm), REF 9-DEL-10F-45/80. Sterile EO. AGA Medical Corporation, 682 Mendels
• Z-0256-2007 · Oct 2, 2006 · Terminated
  Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) AMPLATZER Exchange System, Order no. 9-EXCH-6F-180/80, 9-EXCH-8F-180/80, 9EXCH-9F-45/80,
• Z-0255-2007 · Oct 2, 2006 · Terminated
  Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60,
• Z-0461-06 · Sep 6, 2005 · Terminated
  AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Size 5/4mm, Length 5 mm. Sterile EO. Single Use Only. Manufactured by AGA Medical Corporation, 682 Mendelssohn Avenue, Golde
• Z-0350-05 · Nov 23, 2004 · Terminated
  Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delive