Amplatzer Piccolo™ 9-PDAP-03-02-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05415067030979), received between Nov 8, 2019 and Sep 18, 2026 — classified as 2 deaths, 8 injuries, 1 malfunction.

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

• 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 ↗
• MalfunctionNov 21, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 3 MM X 2 MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR IMPLANT USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE COULD NOT ABLE DEPLOY BECAUSE 2 DISC DID NOT OPEN COMPLETELY AFTER MULTIPLE TRIAL. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PATIENT WAS SENT FOR SURGERY. 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 RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748728 ↗
• InjuryMay 14, 2024Malposition of Device; Patient-Device Incompatibility; Malposition of Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT AN UNKNOWN AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2021 USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. DURING IMPLANT THE DISTAL DISC OF THE DEVICE WAS POSITIONED OUT IN THE AORTA AND THEN THE DEVICE WAS PULLED INTO THE PATENT DUCTUS ARTERIOSUS (PDA). THE MID PORTION OF THE DEVICE WAS UN-SHEATHED. IT WAS NOTED THAT THE DISTAL DISC WAS IN THE AORTA AND THE CONNECTING WAIST AND PROXIMAL DISC WERE IN THE PDA AT A SHARP ANGLE WHERE SOME PORTION OF THE DEVICE PASSED THROUGH THE DUCTUS AND INTO THE AORTA. THE PATIENT REMAINED HEMODYNAMICALLY STABLE BUT THE PHYSICIAN EXPRESSED CONCERN OF A CONNECTION MADE FROM THE PDA TO THE AORTA THROUGH THE SUPERIOR ASPECT OF THE PDA WITH THE CONNECTING WAIST AND PROXIMAL DISC CLOSING THE PDA. THE DELIVERY SYSTEM APPEARED TO HAVE CROSSED THE TOP OF THE PDA, THROUGH THE PDA WALL, AND THROUGH THE ANTERIOR AORTIC WALL INTO THE LUMEN OF THE AORTA. IT WAS UNKNOWN IF THE DEVICE TORE THE SUPERIOR ASPECT OF THE AMPULLA AND PDA OR WHETHER THERE WAS A PUNCTURE DURING THE SUBSEQUENT DEPLOYMENT, RE-CAPTURE, AND RE-DEPLOYMENT. THE PATIENT WAS MONITORED FOR A CONSIDERABLE AMOUNT OF TIME. NO ATTEMPT WAS MADE TO READJUST T

  Patient problems: Perforation

  MAUDE report 19316074 ↗
• InjuryApr 16, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON 25 MARCH 2024, A AMPLATZER PICCOLO OCCLUDER 3 MM X 2 MM WAS SELECTED FOR AN IMPLANT. THE PDA MINIMAL DIAMETER WAS 1.5MM AND 5.0MM PDA DIAMETER AT AORTIC AMPULLA. THE PDA LENGTH WAS 7.0MM. DURING THE PROCEDURE, THE DEVICE EMBOLIZED IN THE PULMONARY ARTERY DURING DEPLOYMENT AND WAS RETRIEVED FROM THE PATIENT. DEVICE WAS REPLACED WITH AMPLATZER PICCOLO OCCLUDER 5 MM X 4 MM DEVICE THAT COMPLETED THE PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116673 ↗
• InjuryOct 5, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 3MM X 2MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR AN IMPLANT USING A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM(TVLP) IN A 6 WEEK OLD PREEMIE BORN ON (B)(6) 2023 AT 25 WEEKS GESTATION. THE BABY WEIGHED 1.1 KILOGRAMS. THE PATENT DUCTUS ARTERIOSUS (PDA) WAS MEASURED ON BOTH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND FLUORO. THE NARROWEST PORTION OF THE PDA MEASURE 2.0MM WITH A LENGTH OF 8.4MM. THE PICCOLO WAS PLACED INTRADUCTAL VIA THE 4F TORQVUE LP DELIVERY SYSTEM THE PICCOLO WAS SITTING MORE ANTERIOR IN THE DUCT, CLOSER TO THE PA SIDE. UPON RELEASE THE DEVICE EMBOLIZED TO THE LPA. THE BABY REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PHYSICIAN USED A NON-ABBOTT DEVICE TO SNARE THE PICCOLO INTO THE SHEATH AND REMOVED FROM THE BODY. THE BABY REMAINED STABLE AND THE PHYSICIAN PROCEEDED TO MEASURE THE DUCTUS AND IT WAS NOW MEASURING 2.5MM AT THE NARROWEST POINT. THE PHYSICIAN THEN PLACED A 4MM X 2MM AMPLATZER PICCOLO OCCLUDER USING THE SAME 4F TORQVUE LP DELIVERY SYSTEM. THE PICCOLO WAS PLACED INTRADUCTAL AND WAS SUCCESSFULLY DEPLOYED. THE BABY REMAINED STABLE THROUGHOUT THE CASE AND WAS TRANSFERRED BACK TO THE NEONATAL INTENSIVE CARE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17879048 ↗
• InjuryMay 26, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE ARTICLE, "INSTITUTIONAL TREND IN DEVICE SELECTION FOR TRANSCATHETER PDA CLOSURE IN PREMATURE INFANTS", WAS REVIEWED. THIS ARTICLE IS A RETROSPECTIVE SINGLE STUDY EXPERIENCE WITH TRANSCATHETER PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE IN PREMATURE INFANTS AND COMPARE PATIENTS GROUPED BY THE DEVICE USED FOR CLOSURE AND ALSO REPORT TRENDS IN DEVICE SELECTION OVER TIME. THE DEVICES ASSOCIATED WITH THIS STUDY INCLUDED THE MICROVASCULAR PLUG, ¿MVP¿ (MEDTRONIC, MINNEAPOLIS, MN); MICRO PLUG SET, ¿MICRO PLUG¿ (KA MEDICAL, MINNEAPOLIS, MN); AND AMPLATZER PICCOLO OCCLUDER, ¿PICCOLO¿ (ABBOT, SANTA CLARA, CA). CLOSURE OF A PDA IN 58 PREMATURE INFANTS WAS SUCCESSFUL USING THREE COMMERCIALLY AVAILABLE DEVICES, ALL WITH A FAVORABLE SAFETY PROFLE. OVER TIME, THE GROUP GRAVITATED TOWARDS SELECTING THE MICRO PLUG DEVICE IN MOST CASES BECAUSE IT WAS SHORT, VISIBLE, TRACKABLE, DELIVERED THROUGH A SOFT MICROCATHETER, AND RELATIVELY INEXPENSIVE. THIS COMPARISON OF THREE DEVICES IS BASED ON A RETROSPECTIVE ANALYSIS WITH SMALL NUMBERS AND THUS SHOULD BE INTERPRETED WITH CAUTION. [THE PRIMARY AND CORRESPONDING AUTHOR OF THIS STUDY IS (B)(6), (B)(6).]

  Patient problems: Aortic Valve Stenosis; Convulsion/Seizure; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Respiratory Insufficiency; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 17009759 ↗
• DeathApr 14, 2023Migration 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) 2023, A 4MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS CHOSEN FOR PROCEDURE USING A 4F AMPLATZER TORQVUE LOW PROFILE CATHETER. THE PATIENT WAS A 22 DAY OLD, 650 G PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS MEASURED BY ANGIOGRAM AND TRANSTHORACIC ECHOCARDIOGRAM (TTE): MINIMAL DIAMETER OF 2.6MM, DIAMETER AT AORTIC AMPULLA OF 3.5MM, LENGTH OF 7MM. THE 4MM BY 2MM OCCLUDER WAS DEPLOYED BUT APPEARED SLIGHTLY LARGE FOR THE DEFECT, SO IT WAS REMOVED PRIOR TO RELEASE FROM DELIVERY CABLE. A 3MM BY 2MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT, AND THE DEVICE WAS PLACED INTO THE PATENT DUCTUS ARTERIOSUS (PDA), AND IT WAS IMPLANTED INTRADUCTAL. THE DEVICE APPEARED TO BE IN A STABLE POSITION, BUT SHORTLY THEREAFTER, THE DEVICE COMPLETELY DISLODGED AND EMBOLIZED INTO THE PATIENT'S RIGHT PULMONARY ARTERY, CAUSING A PARTIAL OBSTRUCTION. THE DEVICE WAS ATTEMPTED TO BE RETRIEVED VIA TRANSCATHETER SNARE. DURING RETRIEVAL OF THE DEVICE, THE PATIENT HAD A PROMINENT SUBCUTANEOUS CHEST WALL HEMORRHAGE, WHICH WAS RELATED TO THE PATIENT'S PAST MEDICAL HISTORY OF BLEEDING DIATHESIS. BLOOD TRANSFUSIONS WERE ADMINISTERED, AND CHEST COMPRESSIONS WER

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion

  MAUDE report 16744378 ↗
• InjurySep 7, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A 3/2 AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A (B)(6) PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: PDA MINIMAL DIAMETER OF 2.3 MM, PDA LENGTH OF 10.8 MM AND DIAMETER AT AORTIC AMPULLA OF 4.0 MM. DURING THE PROCEDURE THE DEVICE WAS PLACED INTRADUCTALLY, BUT WAS MIS-SIZED TOO SMALL. THE OCCLUDER WAS FOUND TO BE PROTRUDING INTO THE PULMONARY ARTERY (PA). IT WAS THOUGHT THAT THE DEVICE MIGHT SIT DIFFERENTLY ONCE DETACHED FROM THE DELIVERY CABLE, SO THE DEVICE WAS FULLY DETACHED. THIS DIDN'T FIX THE ISSUE SO THE DEVICE WAS THEN SNARED SUCCESSFULLY AND REMOVED FROM THE PATIENT. A 4/2 AMPLATZER PICCOLO OCCLUDER WAS THEN SELECTED AND SUCCESSFULLY PLACED INTRADUCTALLY. THE PROCEDURE WAS NOT EXTENDED LONGER THAN IS CLINICALLY SIGNIFICANT AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE WITH NO ADVERSE CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436577 ↗
• InjuryDec 24, 2020Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  ON (B)(6) 2020, A 3/2 AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A (B)(6) WEEK OLD, (B)(6) G PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS(PDA) DIMENSIONS OF: 1.6MM AT THE PA END OF THE DUCT AND A LENGTH OF 10MM. DURING THE PROCEDURE THE DEVICE WAS PLACED INTRADUCTAL, BUT THE DEVICE INITIALLY PULLED THROUGH THE DUCT WHILE ATTEMPTING TO PLACE IT, SO THE DUCT WAS RECROSSED AND THE PHYSICIAN ATTEMPTED TO PLACE THE DEVICE AGAIN. AFTER MULTIPLE ATTEMPTS AT REPOSITIONING THE DEVICE, THE PHYSICIAN WAS ABLE TO GET THE DEVICE IN WHAT WAS DEEMED TO BE A GOOD POSITION. THE PHYSICIAN NOTICED THAT THE DEVICE INITIALLY MOVED AFTER BEING RELEASED, SO THE PHYSICIAN WATCHED IT FOR A COUPLE OF MINUTES, BUT THE DEVICE ULTIMATELY EMBOLIZED INTO THE LEFT PULMONARY ARTERY (LPA) WITHIN A FEW MINUTES OF RELEASING IT. THE PHYSICIAN WAS ABLE TO QUICKLY REMOVE THE DEVICE WITH MINIMAL DIFFICULTY USING A 5MM GOOSENECK SNARE AND A 4FR COOK FLEXOR SHEATH. THE DECISION THE WAS MADE TO ATTEMPT CLOSURE WITH A 4/2 AMPLATZER PICCOLO OCCLUDER. AFTER REPOSITIONING THIS DEVICE IN THE DUCT A COUPLE OF TIMES, THE PHYSICIAN WAS ABLE TO GET THE DEVICE IN A GOOD POSITION WITHIN THE DUCT. HOWEVER, ECHO INTER

  Patient problems: Embolism

  MAUDE report 11073256 ↗
• InjuryJul 15, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020, A 3-2 AMPLATZER PICCOLO WAS SELECTED FOR IMPLANT FOR A (B)(6) OLD (B)(6) GRAM PATIENT. THE PATIENT HAS A PATENT DUCTUS ARTERIOSUS (PDA) OF: MINIMUM DIAMETER : 1.7MM, AMPULLA: 3.5MM, LENGTH: 6.0 - 7.0MM. THE DEVICE WAS PLACED INTRADUCTAL. UPON RELEASE, THE DEVICE EMBOLIZED TO THE PULMONARY ARTERY. THE DEVICE WAS SNARED WITH A NON-ABBOTT DEVICE. WHILE RETRIEVING THE OCCLUDER, THE TRICUSPID VALVE WAS INJURED BY THE NON-ABBOTT SHEATH. THE PDA BECAME SMALLER POST PROCEDURE AND IS BEING MONITORED. THE PATIENT IS STABLE WITH NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Tricuspid Insufficiency

  MAUDE report 10276106 ↗
• DeathNov 8, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2019, A 4/2MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A (B)(6) GESTATIONAL, FEMALE PATIENT WEIGHING (B)(6)G. THE PDA WAS NOTED TO BE APPROXIMATELY 2MM AT THE MINIMAL DIAMETER AND 3-3.2MM AT THE AORTIC AMPULLA (DEVICE PLACEMENT: INTRADUCTAL). THE DEVICE WAS IMPLANTED AND RE-POSITIONED; HOWEVER, THE ECHOCARDIOGRAPHER NOTED THE PROXIMAL DISC WAS IMPINGING ON THE LPA. THE DEVICE WAS RECAPTURED AND A 3/2MM AMPLATZER PICCOLO OCCLUDER (LOT NUMBER: 6961517) WAS IMPLANTED. THE 3/2MM DEVICE EMBOLIZED TO THE RPA AND WAS SUCCESSFULLY RETRIEVED USING A GOOSENECK SNARE. THE FIRST 4/2MM AMPLATZER PICCOLO OCCLUDER WAS SUCCESSFULLY IMPLANTED WITH NO MIGRATION. FOLLOWING THE RELEASE OF THE DEVICE, AN ULTRASOUND WAS PERFORMED AND REVEALED DAMAGE TO THE TRICUSPID VALVE. THE PATIENT WAS UNABLE TO RECOVER AND WAS REPORTED TO HAVE EXPIRED THE SAME DAY.

  Patient problems: Death; Embolism

  MAUDE report 9296674 ↗

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