Nanoparasol, Peel Away PNP6514C-190-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429117231), received between Sep 2, 2025 and Sep 29, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Retraction Problem” (2 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 18, 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.

• InjurySep 29, 2026Retraction Problem; Material Separation

  It was reported that during the carotid procedure, the Nanoparasol was properly prepared and loaded the EPD with the 0.014" guidewire in accordance with the Instructions for Use (IFU) and placed in the ICA, with the EPD successfully positioned. While peeling off the green protection tube, the EPD was successfully opened, and the green protection tube was taken out. After loosening the torquer, the user advanced the dilation balloon catheter, he felt significant resistance and he found that the Nanoparasol was closed. At that point, the users noticed a different tactile sensation and continued peeling the remaining 30cm protection catheter tube. They experienced some resistance and, based on the NanoParasol demonstration video, believed that the entire protection tube should be removable. However, when they continued to pull the tube, it fractured. He noticed that a portion of the protection tube was broken and left in the body (still in the NanoP wire). The user was initially unaware that part of the protection tube remained within the guidewire. Upon further inspection, the user identified that the distal 30cm portion was still inside the 0.014" wire. The whole entire NanoP system

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927072 ↗
• MalfunctionSep 2, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED: A SECOND NANOPARASOL WAS OPENED. THE .014 CROSSING WIRE WAS ADVANCED ONCE AGAIN THROUGH THE LESION, FOLLOWED BY THE SECOND NANOPARASOL. WHEN THE NANOPARASOL WAS PARKED IN THE CORRECT LOCATION, THE PHYSICIAN LOOSENED THE TORQUE AND HUBBED IT UP AGAINST THE RHV. GREEN SHEATH WAS THEN PULLED OUT OF THE TORQUE DEVICE AND THEN WALKED OFF THE WIRE. AFTER A FLUORO SHOT WAS THEN TAKEN, THE NANOPARASOL HAD CROSSED BACK THROUGH THE LESION AND INTO THE COMMON CAROTID ARTERY. THE .014 WIRE WAS STUCK AND WOULDN'T COME BACK THROUGH THE FILTER. WE WERE ABLE TO PARTIALLY RETRIEVE THE FILTER BACK INTO THE 5FR 90CM COOK SHUTTLE SHEATH, BUT COULDN'T GET THE FILTER TO FULLY COMPRESS BACK INTO THE SHEATH TO BRING IT ALL THE WAY OUT. IT WAS THEN DETERMINED TO PULL EVERYTHING OUT AND START AGAIN. RADIAL ACCESS WAS GAINED ONCE AGAIN, 90CM SHUTTLE SHEATH WAS PARKED IN THE CCA, NAV6 EMBOLIC PROTECTION DEVICE WAS USED DISTAL TO THE LESION, AND ROADSAVER STENT WAS SUCCESSFULLY DEPLOYED AFTER A BALLOON PRE DIL. POST DILATATION WAS THEN PERFORMED, AND EVERYTHING WAS REMOVED AND TR BAND APPLIED. PATIENT IS STABLE AND DOING GREAT. IT IS NOTED PATIENT'S PRE-PROCEDURAL CONDITION LISTED AS INTERNAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929735 ↗