Nit-Occlud PDA 145116V2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042301160034), received between Dec 11, 2015 and Feb 7, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

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

  THE COIL WENT OUT OF THE TRANSPORTATION SHEATH. DOCTOR'S REPORT: "AFTER INTRODUCING THE COIL, WE TRIED TO REPOSITION IT. AT THE FIRST TRIAL OF REPOSITION THE LOOPS STUCKED ON THE CATHETER AND REFUSED TO GO BACK INSIDE THE CATHETER OR REFIGURED AGAIN AT ALL. AFTER FLUSHING THE SYSTEM SEVERAL TIMES, WE TRIED TO PULL IT HARDER TO LET IT MOVE, THEN IT'S WENT OUT OF THE TRANSPORTATION SHEATH." COULD RESULT IN EMBOLISM OF THE DEVICE IS OCCURRED AGAIN REQUIRED INTERVENTION TO REMOVE THE DEVICE.

  Patient problems: No Information

  MAUDE report 8316341 ↗
• MalfunctionDec 11, 2015Activation, Positioning or Separation Problem

  EVENT DESC: SERIAL NUMBER: (B)(4). THE NIT-OCCLUD RELEASED PREMATURELY AND WAS SURGICALLY REMOVED. ADDITIONAL INFORMATION 11/13/2015: NIT-OCCLUD EMBOLIZED BEFORE SECURED IN THE PDA. PATIENT AGE: (B)(6). MEASURED DUCTUS SIZE: AORTIC 31, PULMONARY 9, LENGTH: 12.1. PROCEDURE DURATION: 7 HOURS. PDA ACCESS: VENOUS 6 FR, AORTAL 5FR. THE ADO 8X6 WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PHYSICIAN DID NOT NOTICE RESISTANCE DURING FORWARDING OR RETRIEVAL INTO THE IMPLANTATION CATHETER. CURVATURE OF IMPLANTATION IN THE VESSEL: MILD. THE PHYSICIAN DID NOT NOTICE A GAP BETWEEN PUSHER AND COIL PRIOR TO RELEASE. THERE WERE NO ROTATIONS, RELEASED WITHOUT USING THE BALL. EMBOLIZED PRIOR TO RELEASE OUTSIDE PDA, IN AORTA. THE PATIENT WAS MOVED TO SURGERY TO HAVE THE DEVICE REMOVED BY A DIFFERENT PHYSICIAN. THE PHYSICIAN DID A CUT DOWN TO REMOVE THE DEVICE, THE PATIENT TOLERATED IT WELL. NO SAMPLE HAS BEEN RETURNED SO FAR. PFM RECEIVED 4 PICTURES SHOWING THE SCREEN OF THE FLUOROSCOPY MONITOR. THE LAST 3 SHOW THE ATTEMPTS TO RETRIEVE THE DEVICE BY SNARING AND GRASPING IT WITH MINIMALLY INVASIVE INSTRUMENTS, THE FIRST SHOWS THE ANGIOGRAPHIC MEASUREMENTS PERFORMED PRIOR IMPLANTATION TO DETERMINE THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5297387 ↗