Nit-Occlud PDA 145096V2Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04042301160010), received between Apr 26, 2018 and Feb 7, 2019 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2019Use of Device Problem; Use of Device Problem

  THE COIL WAS RELEASED INSIDE THE PATIENT. DOCTOR'S REPORT: "WE TRIED WITH A COIL AND DURING CONFIGURATION OF THE LAST TWO LOOPS, IS STUCK IN THE CATHETER REFUSING TO GET OUT OR TO GET BACK IN THE CATHETER WE TRIED A LOT UNTIL IT'S RELEASED IN IMPROPER POSITION WHICH FORCE TO SNARE IT AND SEND THE PATIENT TO SURGERY."

  Patient problems: No Information

  MAUDE report 8316344 ↗
• MalfunctionFeb 6, 2019Use of Device Problem; Use of Device Problem

  PREMATURE DEPLOYMENT. PHYSICIAN WAS POSITIONING THE NIT-OCCLUDE IN THE PDA WHEN THE DEVICE, "POPPED OFF." THE DEVICE JUMPED FORWARD BUT NOT COMPLETELY INTO THE AORTA. PHYSICIAN WAS ABLE TO SNARE THE DEVICE OUT AND PLACED AN AMPLATZER DEVICE. THE CURVATURE OF IMPLANTATION CATHETER IN THE VESSEL WAS MILD. THE PHYSICIAN DID NOT NOTICE A GAP BETWEEN PUSHER AND COIL PRIOR TO RELEASE. THE PHYSICIAN DID NOT MOVE THE ROTATION SCREW FORWARD AT ALL. WHEN THE DEVICE DEPLOYED ON ITS OWN, IT JUMPED FORWARD AND WAS POORLY POSITIONED IN THE PDA WITH MANY COIL HANGING OUT INTO THE AORTA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8313046 ↗
• MalfunctionFeb 6, 2019Use of Device Problem; Use of Device Problem

  THE COIL WAS NOT ATTACHED. UPON DEPLOYMENT, THE COIL CURLED THROUGH THE PIGTAIL CATHETER. WHEN PHYSICIAN TRIED TO RESHEATH, IT WAS DISCOVERED THAT THE COIL WAS NOT ATTACHED. ONLY ABOUT 1 THIRD OF THE COIL WAS OUT. THERE WAS NO PROBLEM DURING THE PREP OR INSERTION OF THE DEVICE INTO THE CATHETER. THE NIT-OCCLUD DID MOVE TO THE PROPER POSITIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8313017 ↗
• MalfunctionFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE NIT-OCCLUD WAS SUCCESSFULLY IMPLANTED. AFTER IMPLANTATION, THE PHYSICIAN WAITED AND WITHIN 10 MINUTES, THE PRODUCT DISLODGED AND MIGRATED TO THE DAO. PHYSICIAN WAS ABLE TO SNARE THE NIT-OCCLUD AND RETRIEVE IT SUCCESSFULLY, WITH NO HARM TO THE PATIENT. PHYSICIAN SUCCESSFULLY IMPLANTED AN AMPLATZ DUCT OCCLUDER TO COMPLETE THE PROCEDURE. PHYSICIAN WAS TREATING A TYPE A PDA. PATIENT AGE: (B)(6) YRS. WEIGHT: (B)(6) KG. MEASURED DUCTUS SIZE (MM) - AORTIC: 9.3, PULMONARY: 1.6, LENGTH 7.6. PROCEDURE DURATION: 139 MINUTES. PDA ACCESS WAS BOTH VENOUS AND AORTAL. A 6FR INTRODUCER SHEATH WAS USED. HEPARIN (SYSTEMIC): 1800 IU/KG. ONE FLUSHING. IT IS UNKNOWN HOW MANY REVOLUTIONS THE PHYSICIAN MOVED THE ROTATION SCREW.

  Patient problems: Embolism; Foreign Body In Patient

  MAUDE report 8308707 ↗
• InjuryJul 20, 2018Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  DEVICE EMBOLIZATION TO DESCENDING ABDOMINAL AORTA. INITIAL CATH: (B)(6) 2018, TYPE A-PDA, MIN DIAMETER 2.7MM, AMPULLA 8MM, DAO 9MM. SUCCESSFUL CLOSURE 9X6 NIT-OCCLUDE. NORMAL PULMONARY ARTERY PRESSURES. EVENT: DEVICE NOTED TO HAVE EMBOLIZED AT CLINIC VISIT (B)(6) 2018. REPEAT CATH: (B)(6) 2018, SUCCESSFUL TRANSVENOUS RETRIEVAL AND CLOSURE OF PDA WITH ADO-2 DEVICE. PROCEDURE DURATION: 97 MINS (INITIAL PROCEDURE), 106 MINS (SECOND CATH). PDA ACCESS: VENOUS. THE SIZE AND TYPE OF INTRODUCER SHEATH USED: FIRST CATH 5FR VENOUS, SECOND CATH 6FR VENOUS. HEPARIN (SYSTEMIC): I.U./KG 100/KG WITH MANY FLUSHINGS. PHYSICIAN DID NOT NOTICE HIGH RESISTANCE DURING FORWARDING OR RETRIEVAL OF THE SYSTEM INTO THE IMPLANTATION CATHETER. CURVATURE OF IMPLANTATION CATHETER IN THE VESSEL: STRAIGHT. THE PHYSICIAN DID NOT NOTICE A GAP BETWEEN PUSHER AND COIL PRIOR TO RELEASE. IT IS UNKNOWN HOW MANY REVOLUTIONS THE PHYSICIAN MOVED THE ROTATION SCREW FORWARD FOR RELEASE.

  Patient problems: Embolism; Foreign Body In Patient

  MAUDE report 7708201 ↗
• MalfunctionApr 26, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT ADMITTED FOR RIGHT AND LEFT HEART CATHETERIZATION, ANGIOGRAMS -LV, AO, MULTIPLE ANGIOGRAMS AT AORTIC ISTHMUS, AND DEVICE CLOSURE OF PATENT DUCTUS ARTERIOSUS. NIT-OCCLUD DISLODGED OUT OF PDA AND WAS STUCK IN THE TRICUSPID VALVE. NIT-OCCLUD LEFT IN THE TRICUSPID VALVE AREA. PDA CLOSURE OBTAINED WITH VASCULAR PLUG II 8MM; NO RESIDUAL PATENT DUCTUS ARTERIOSUS. ATTEMPT MADE AT REMOVAL OF NIT-OCCLUD BY TRANSCATHETER TECHNIQUE UNSUCCESSFUL. US PEDS ECHO POST INCIDENT - COIL DEVICE IS DISPLACED WITHIN THE TRICUSPID VALVE ANNULUS, DEVICE APPEARS STABLE WITH NO OBSTRUCTION TO FLOW. ECHO REPEATED TWICE MORE WITH CONTINUED REPORT OF STABILITY WITH NO OBSTRUCTION TO FLOW. THE PATIENT WAS DISCHARGED ON (B)(6) 2018 IN STABLE CONDITION. PDA ACCESS WAS VENOUS. ACCOUNT STATES THAT THIS WAS NOT A DEVICE ERROR, BUT AN OPERATIONAL ERROR. NO OTHER INFORMATION IS BEING MADE AVAILABLE BY THE ACCOUNT.

  Patient problems: Device Embedded In Tissue or Plaque; Embolism; Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7466296 ↗