Amplatzer Piccolo™ 9-PDAP-04-06-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067031020), received between Jun 13, 2021 and Apr 4, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4X6MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT USING AN UNKNOWN SIZED ABBOTT DELIVERY SYSTEM. DURING ARTERY APPROACH, "WHEN THE PA SIDE SKIRT WAS DEPLOYED" THE DEVICE REPEATEDLY SHOWED AN ELONGATED/BULBOUS DEFORMATION. THE DEVICE WAS ATTEMPTED TO BE PLACED INTRADUCTAL. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND REMOVED. NO DEVICE WAS ULTIMATELY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774817 ↗
• InjuryMar 25, 2022Migration 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) 2022, A 4/6 AMPLATZER PICCOLO WAS SUCCESSFULLY IMPLANTED IN A (B)(6), (B)(6) PATIENT IN THE INTRADUCTAL POSITION. THE PATIENT HAD THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) DIMENSIONS: PDA MINIMAL DIAMETER OF 1.9 MM, PDA LENGTH OF 10-12 MM AND DIAMETER AT AORTIC AMPULLA OF 5.3 MM. OVERNIGHT, THE DEVICE HAD BECAME EMBOLIZED AND TRAVELED INTO THE DISTAL LEFT PULMONARY ARTERY (LPA). IN AN EMERGENCY PROCEDURE ON (B)(6) 2022, THE DEVICE WAS REMOVED VIA TRANSCATHETER SNARE TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT AND IS CURRENTLY STABLE. THE PHYSICIAN ALLEGES THE CAUSE OF THE EVENT TO BE DUE TO THE DEVICE BEING UNDERSIZED. IT WAS UNKNOWN IF THE DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13911532 ↗
• InjuryJun 13, 2021Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  IT WAS REPORTED THAT A 4/6MM AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A (B)(6) MONTH OLD, (B)(6) KG PATIENT ON (B)(6) 2021. THE PATIENT HAD THE FOLLOWING PATENT DUCTUS ARTERIOSUS(PDA) DIMENSIONS: MINIMAL DIAMETER OF 2.3MM, LENGTH OF 9.8MM AND A DIAMETER AT THE AORTIC AMPULLA OF 2.3MM. DURING THE PROCEDURE THE DEVICE WAS SUCCESSFULLY PLACED INTRADUCTAL WITH EXTRADUCTAL PLACEMENT OF THE PULMONARY DISC. 5 TO 6 HOURS POST-PROCEDURE, IT WAS NOTED THAT THE DEVICE MIGRATED FROM THE IMPLANT SITE(PDA) INTO A BRANCH OF THE PULMONARY AORTA. THE PATIENT UNDERWENT SURGICAL REMOVAL OF THE DEVICE AND SURGICAL CLOSURE OF THE PDA. THE PATIENT IS CURRENTLY STABLE AND THE DEVICE HAS BEEN DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body Embolism

  MAUDE report 11989082 ↗

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