Nit-Occlud PDA 145076V2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042301159991), received between Oct 10, 2017 and Feb 6, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN REPORTED AN AWFUL PREMATURE RELEASE. PHYSICIAN FORGOT TO CHECK THAT THE DEVICE WAS ATTACHED TO THE CABLE, WHEN THE PDA COIL (LAST LOOP) WAS DEPLOYED, THE DEVICE RELEASED. IT DID RELEASE IN A GOOD POSITION, WAS STABLE, AND THE SHUNT DIMINISHED TO TRIVIAL WITH RESOLUTION OF THE MURMUR IN 12 MINUTES. THE PHYSICIAN DID NOT NOTICE HIGH RESISTANCE DURING FORWARDING OF THE SYSTEM INTO THE IMPLANTATION CATHETER. PHYSICIAN DID NOT NOTICE A GAP BETWEEN PUSHER AND COIL PRIOR TO RELEASE. IF ISSUE RECURRED IT COULD LEAD TO EMBOLIZATION OF THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8313090 ↗
• MalfunctionFeb 6, 2019Unintended Ejection; Unintended Ejection

  THE COIL SEPARATED FROM THE DELIVERY SYSTEM WHILE IN THE CATHETER. IT WAS RETRIEVED WITHOUT INCIDENT. PHYSICIAN CONFIGURED COIL IN THE DESCENDING AORTA, PULLED SYSTEM BACK INTO DEFECT, SUSPECTED POTENTIAL COARC AND DECIDED TO RETRIEVE / RE-CONFIGURE. UPON SHEATH RE-ENTRY, COIL DETACHED FROM MANDREL WIRE. A 5X4 ADO I WAS USED TO COMPLETE THE PROCEDURE. PHYSICIAN DID NOT NOTICE HIGH RESISTANCE DURING FORWARDING OR RETRIEVAL OF THE SYSTEM INTO THE IMPLANTATION CATHETER. CURVATURE OF THE IMPLANTATION CATHETER IN THE VESSEL WAS MILD. THE PHYSICIAN DID NOT NOTICE A GAP BETWEEN THE PUSHER AND COIL PRIOR TO RELEASE. THE PHYSICIAN DID NOT MOVE THE ROTATION SCREW FORWARD AT ALL. IN THE FILM, A GAP IS NOTICEABLE BETWEEN THE PUSHER WIRE AND THE DEVICE; APPROXIMATELY 1CM OR MORE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8313083 ↗
• MalfunctionOct 10, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  WHEN THE COIL WAS EXTRUDED INTO THE PROXIMAL DESCENDING AORTA, THE LEADING EDGE LODGED ITSELF INTO THE AORTA. IT WAS EXTREMELY DIFFICULT TO GET OUT. DURING THE PROCESS OF ATTEMPTING TO REMOVE IT (USING CATHETERS FROM THE ARTERIAL SIDE TO PRY IT AWAY FROM THE AORTA, AS WELL AS PULLING WITH A SNARE), THERE WAS PREMATURE RELEASE OF THE DELIVERY SYSTEM FROM THE DEVICE. AT THAT POINT, DEVICE WAS HALF WITHIN THE CATHETER AND HALF OUTSIDE. PHYSICIAN WAS ABLE TO SNARE IT AND PULL IT OFF THE AORTA, AND SUBSEQUENTLY PULLED BOTH THE SNARE AND DELIVERY CATHETER BACK THROUGH THE PDA INTO THE MAIN PULMONARY ARTERY AND THEN TO THE IVC WHERE IT COULD BE DEALT WITH BETTER WITHOUT RISK OF DANGEROUS EMBOLIZATION. ONCE THERE WITHIN THE IVC, PHYSICIAN WAS ABLE TO GET A BETTER HOLD WITH THE SNARE AND PULLED IT INTO THE SHEATH. SOME CAME THROUGH AND THEN, WHILE PULLING, THE COIL BROKE IN HALF. PHYSICIAN WAS ABLE TO WITHDRAW FIRST HALF, AND THEN RE-SNARE THE REMAINING HALF AND REMOVE IT. PHYSICIAN THEN PLACED THE NEXT SIZE NIT-OCCLUD COIL AND EXTRUDED IT INTO DESCENDING AORTA. UPON PULLING BACK INTO THE AMPULLA, IT EASILY PULLED ACROSS THE PDA INTO THE PULMONARY ARTERY DESPITE HAVING REPEATED AN ANGIOGRAM

  Patient problems: Foreign Body In Patient; Vessel Or Plaque, Device Embedded In

  MAUDE report 6938883 ↗