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Nit-Occlud PDA 145054V2Recalls & reported problems

pfm medical ag · Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath. · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042301159953), received between Feb 4, 2020 and Feb 4, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Positioning Problem1

Patient problems

  • Embolism1
  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

    PHYSICIAN PERFORMED A STANDARD PDA PROCEDURE, MEASURED AND DECIDED TO USE A 5X4 NIT-OCCLUD. PHYSICIAN FOLLOWED ALL IFU INSTRUCTIONS BEFORE RELEASE AND AFTER DEPLOYMENT SAW THAT THERE WAS STILL RESIDUAL FLOW THROUGH THE DUCTUS. AFTER WAITING AN ADDITIONAL FIVE MINUTES, THERE WAS STILL FLOW. PHYSICIAN WENT UP WITH A CATHETER TO SEE IF AN ADDITIONAL COIL COULD BE PUT IN TO STOP THE FLOW. WHILE WORKING WITH THE CATHETER AROUND THE NIT-OCCLUD, IT BECAME DISLODGED AND WENT INTO THE TRICUSPID VALVE. WHEN THE COIL WAS RETRIEVED AND OUT OF THE BODY, THE COIL WAS COMING OFF OF THE INNER CORE WIRE. THIS MAY HAVE HAPPENED IN THE SNARING PROCESS. PHYSICIAN USED A SNARE TO GET IT OUT AND THEN USED AN AMPLATZER TO CLOSE THE PDA. MEASURED DUCTUS SIZE (MM): AORTIC 3.2, PULMONARY 1.3, LENGTH 3.9. PROCEDURE DURATION: 128 MINUTES. PDA ACCESS: VENOUS AND AORTAL. A COOK 7F INTRODUCER SHEATH WAS USED. HEPARIN (SYSTEMIC) IU/KG: 1500 UNITS - DON'T GIVE HEPARIN BUT BECAUSE OF THE ISSUE THEY DID. THEY USE A MANIFOLD BAG. THE PHYSICIAN DID NOT NOTICE HIGH RESISTANCE DURING FORWARDING OR RETRIEVAL OF THE SYSTEM INTO THE IMPLANTATION CATHETER. CURVATURE OF IMPLANTATION CATHETER IN THE VESSEL WAS STRAIGHT. THE P

    Patient problems: Embolism; Foreign Body In Patient

    MAUDE report 9668243 ↗

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Sources and updates

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