Amplatzer Piccolo™ 9-PDAP-05-06-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05415067031051), received between Sep 17, 2019 and Jan 2, 2026 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryOct 15, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 5 MM X 6 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE PROCEDURE USING AN UNKNOWN DELIVERY SYSTEM. THE PATIENT'S AGE AT TIME OF PROCEDURE WAS 4 MONTH AND THE PATIENT'S GESTATIONAL AGE WAS 24 WEEKS. THE PATIENT'S WEIGHT WAS 3K. THE PDA MINIMAL DIAMETER WAS 3.9MM AND PDA DIAMETER AT AORTIC AMPULLA WAS 4.1MM AND PDA LENGTH 8.9MM. THE SIZE OF THE DEFECT WAS 3.9MM X 8.9. THE SIZING OF THE DEVICE DETERMINED BY TRANSTHORACIC ECHOCARDIOGRAM (TTE). THE OCCLUDER WAS SUCCESSFULLY IMPLANTED AND STABILITY CHECK WAS PERFORMED. THERE WAS A PERI DEVICE LEAK. NEXT DAY, IT WAS NOTED THAT THE DEVICE WAS EMBOLIZED AND CAUSING OBSTRUCTION PARTIAL TO THE RIGHT PULMONARY ARTERY (RPA). THE CAUSE OF EMBOLIZATION WAS MIS-SIZING. THE OCCLDER WAS EXPLANTED VIA PERCUTANEOUS RETRIEVAL AND A NEW 5-4MM AMPLATZER DUCT OCCLUDER WAS IMPLANTED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Coronary obstruction/occlusion

  MAUDE report 23303043 ↗
• MalfunctionJun 2, 2025Malposition of Device; No Apparent Adverse Event; Malposition of Device; No Apparent Adverse Event

  IT WAS REPORTED THAT (B)(6) 2025, A 5 MM X 6 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE PROCEDURE USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. DURING PROCEDURE, WHEN USING THE PRODUCT, IT WAS DEPLOYED IN AN EXTENDED FORM AGAINST THE TARGET PDA. THE DEVICE WAS REMOVED AND A NEW 5 MM X 4 MM AMPLATZER PICCOLO OCCLUDER 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 22123543 ↗
• InjuryFeb 7, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 5MM X 6MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2025 FOR A 15 WEEK OLD PATIENT WITH A WEIGHT OF 6KG, AND A MINIMAL DUCTAL DIAMETER OF 2.2MM AND A DUCTAL LENGTH OF 6MM TO TREAT A PATENT DUCTAL ARTERIOSUS (PDA). THE PATIENT WAS BORN CLOSE TO FULL-TERM WITH A SIGNIFICANT ATRIAL SEPTAL DEFECT (ASD), PDA, AND VASCULAR SEPTAL DEFECT (VSD) AND REQUIRED 15 MINUTES OF CARDIOPULMONARY RESUSCITATION (CPR) AND RESUSCITATION AT BIRTH. THE PATIENT ALSO HAD TRACHEAL INTUBATION. SIZING OF THE DEVICE WAS DETERMINED WITH ANGIOGRAPHY. FLUOROSCOPY AND ECHOCARDIOGRAM WERE USED DURING THE PROCEDURE. DURING THE PROCEDURE THE OCCLUDER WAS PLACED FROM THE AORTA TO THE PULMONARY ARTERY AND ON THE FIRST DEPLOYMENT THE OCCLUDER PULLED THROUGH THE DUCTUS. THE OCCLUDER WAS RE-CAPTURED AND RE-DEPLOYED. LIMITED FLOW WAS OBSERVED ON THE SUPERIOR SIDE OF THE OCCLUDER AND CONTRAST INJECTION DONE FROM THE DELIVERY CATHETER SHOWED VERY LITTLE FLOW THROUGH AND AROUND THE DEVICE. A TUG TEST WAS PERFORMED AND THE USER STATED THE OCCLUDER FELT ANCHORED IN THE PDA BY THE PATIENT'S EXTRA DUCTAL DISKS. AS THE OCCLUDER WAS RELEASED THE OCCLUDER EMBOLIZED TO THE LEFT PULMONARY ART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334451 ↗
• InjuryDec 20, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE IN A 3.5 KG PATIENT USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS WERE 10.5 MM LONG, 5.7 MM AORTIC AMPULLA, 2.3 MM TIGHTEST SECTION MID DUCTUS IN LATERAL VIEW ALMOST CREATING A HAIRPIN DUCTUS CONFIGURATION. IN ANTERIOR-POSTERIOR (AP) VIEW TIGHTEST PORTION WAS PRONOUNCED AND MEASURED AT 0.8 MM INITIALLY. AS PER SIZING CHART 4 MM X 6 MM AMPLATZER PICCOLO OCCLUDER WAS RECOMMENDED BUT DUE TO PATIENT'S ACCOMMODATING AMPULLA LARGE LENGTH OF THE DUCTUS AND TIGHT SECTION NEAR A HAIRPIN LIKE TURN, PHYSICIAN DECIDED TO MOVE WITH THE 5 MM X 2 MM AMPLATZER PICCOLO OCCLUDER. UPON INITIAL PLACEMENT WHILE ON THE CABLE A FEW PDA-GRAMS WERE ACQUIRED FROM A PIG TAIL IN THE AORTA WITH A POWER INJECTOR AND THROUGH THE DELIVERY CATHETER. FLOW APPEARED TO MOVE DIRECTLY THROUGH THE FRAME OF THE DEVICE AS IT STRADDLED THE HAIRPIN CONFIGURATION. BECAUSE THERE WAS SO MUCH ROOM AND FLOW THROUGH THE DEVICE THE PHYSICIAN DECIDED A LARGER WAIST WOULD LIKELY HELP FILL THE HAIR PIN PORTION BETTER. THE 5 MM X 2 MM AMPLATZER PICCOLO

  Patient problems: Hypoxia; Obstruction/Occlusion

  MAUDE report 18366175 ↗
• InjuryDec 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, ¿RISK FACTORS ASSOCIATED WITH DEVICE EMBOLISATION OR MALPOSITION DURING TRANSCATHETER CLOSURE OF PATENT DUCTUS ARTERIOSUS¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 1 MONTH OLD PATIENT WEIGHING 2.8 KG WITH RUBELLA. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 5-6MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT TO TREAT PATENT DUCTUS ARTERIOSUS (PDA) THAT WAS SIZED 4.5 MM. DURING DEPLOYMENT, THERE WAS SIGNIFICANT RESIDUAL FLOW WITH THE DEVICE AND A DECISION WAS MADE TO RETRIEVE THE DEVICE AND REPLACE WITH A 6-4MM NON-ABBOTT CONVENTIONAL DUCT OCCLUDER. THE ARTICLE CONCLUDED DEVICE EMBOLISATION COMPLICATES 4% OF TRANSCATHETER DUCT CLOSURES, WITH NEED FOR SURGERY IN ONE-FIFTH OF THEM. LARGER DUCTS WITH HIGH PULMONARY ARTERY PRESSURES IN YOUNGER AND SMALLER INFANTS ARE MORE OFTEN ASSOCIATED WITH DEVICE EMBOLISATION. TUBULAR DUCTS ARE MORE PRONE FOR EMBOLISATION COMPARED TO USUAL CONICAL DUCTS. SOFTER VASCULAR PLUGS ARE OFTEN ASSOCIATED WITH EMBOLISATIONS. INTENTIONAL DEVICE UNDERSIZING TO AVOID VASCULAR OBSTRUCTION IN SMALL PATIENTS IS A FREQUENT RISK FACTOR FOR EMBOLISATION. PRECISE ECHOCARDIOGRAPHIC MEASUREMENTS, CORRECT OCCLUDER CHOICE, PROPER TECHNIQUE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278606 ↗
• MalfunctionNov 7, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18086320 ↗
• InjuryJun 15, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5MM BY 6MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT IN A 8.3KG PATIENT WITH A PATENT DUCTUS ARTERIOSUS (PDA) USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE PDA MINIMAL DIAMETER WAS 2.8MM AND PDA DIAMETER AT AORTIC AMPULLA WAS 10.5MM. THE PICCOLO WAS DEPLOYED AND RELEASED. AFTER THREE HEART BEATS, IT WAS SEEN ON CINE IMAGING THAT THE DEVICE EMBOLIZED INTO THE PULMONARY ARTERY (PA). THE DISLODGED PICCOLO WAS SNARED, DRAWN IT TO THE DELIVERY CATHETER, AND RETRIEVED. THE DEVICE WAS PLACED INTRADUCTAL. A NEW 4MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A NEW 6F AMPLATZER TORQVUE DELIVERY SYSTEM AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS DISCHARGED NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135320 ↗
• MalfunctionMar 23, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT ON (B)(6) 2023, A 5 MM X 6 MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR AN IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING THE PROCEDURE THE DEVICE WAS NOT STABLE IN PATIENT PDA. WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. A 6MM AMPLATZER VASCULAR PLUG 2 WAS SELECTED TO CLOSE THE PATENT DUCTUS ARTERIOSUS (PDA) WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS STABLE. USER CONCERNS: THE PHYSICIAN WAS DISAPPOINTED IN THE PICCOLO DEVICE AND A LITTLE CONFUSED ON SIZING RECOMMENDATIONS. INFORMATION IN PDA BROCHURE ON DEVICE SELECTION IS INCORRECT AND NOT THE SAME AS THAT IN IFU OR AMPLATZER APP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16603492 ↗
• InjuryNov 20, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 5MM X 6MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT. THE SIZING OF THE DEVICE WAS DETERMINED VIA ECHOCARDIOGRAPHY AND FLUOROSCOPY IMAGING. ROUGHLY 7 MINUTES AFTER RELEASE, THE OCCLUDER EMBOLIZED INTO THE PULMONARY ARTERY. THE IMPLANTER BELIEVES THE PLIABLE DUCT DIDN'T ALLOW FOR AN ACCURATE MEASUREMENT OF THE DEFECT. THE MEASURED DIMENSIONS OF THE DEFECT ARE: 8MM LENGTH X 3.4MM DIAMETER. THERE WAS AN ATTEMPT TO SNARE THE DEVICE BUT IT WAS UNSUCCESSFUL AND THE PATIENT UNDERWENT SURGERY TO REMOVE THE DEVICE. THIS WAS CONSIDERED AN EMERGENCY PROCEDURE. IT WAS NOTED THAT THE PATIENT'S STATUS WAS NOTED AS STABLE AND THE SURGERY WAS SUCCESSFUL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15831476 ↗
• InjuryAug 18, 2021Migration 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 ON (B)(6) 2021, A 5/6 AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A 35 DAY OLD 3 KG PREMATURE PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: PDA MINIMAL DIAMETER OF 4 MM, PDA LENGTH OF 12 MM AND DIAMETER AT AORTIC AMPULLA OF 7 MM. DURING THE PROCEDURE THE DEVICE WAS PLACED INTRADUCTAL, BUT SOON AFTER RELEASING THE DEVICE FROM THE DELIVERY CABLE, THE DEVICE EMBOLIZED INTO THE PULMONARY ARTERY. THE DEVICE WAS SUCCESSFULLY SNARED AND REMOVED FROM THE PATIENT. A 3 MM AMPLATZER DUCT OCCLUDER WAS THEN USED AND SUCCESSFULLY IMPLANTED INTRADUCTALLY TO RESOLVE THE EVENT. THE PROCEDURE WAS NOT EXTENDED LONGER THAN IS CLINICALLY SIGNIFICANT AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339090 ↗
• InjurySep 17, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  (B)(6) BABY WITH A PATENT DUCTUS ARTERIOSUS (DIMENSIONS NOT PROVIDED) UNDERWENT TRANSCATHETER PDA CLOSURE USING THE AMPLATZER PICCOLO OCCLUDER. THE AMPLATZER PICCOLO OCCLUDER WAS DELIVERED AND RELEASED WITHOUT DIFFICULTY. THERE WAS NO POST-PROCEDURE IMAGING ASSESSMENT OF THE DEVICE POSITION UNTIL A FEW WEEKS LATER WHEN IT WAS DETERMINED THAT THE DEVICE EMBOLIZED INTO THE LEFT PULMONARY ARTERY. THE INFANT WAS ASYMPTOMATIC AND TAKEN TO THE CATHETERIZATION LABORATORY WHERE THE EMBOLIZED DEVICE WAS RETRIEVED USING A TRANSCATHETER SNARE WITHOUT DIFFICULTY. THE PDA WAS SMALLER IN SIZE AND A DECISION WAS MADE TO NOT ATTEMPT ANOTHER DEVICE IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9077739 ↗

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-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-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-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