NeVa pVasc 6.0 x 44 mm - Flow Restoration, 3 Drop Zones - 180 cm wire System VP-6044-F3RRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00851279008514), received between May 5, 2025 and May 19, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 19, 2026Material Integrity Problem

  DURING THROMBECTOMY OF LOWER LEG (TIBIAL ARTERY) THE PVASC DETACHED FROM THE DELIVERY WIRE WHILE TRYING TO REMOVE DEVICE FROM BODY. LARGE PIECE OF TISSUE (NOT CLOT) WAS TRAPPED BETWEEN THE TIP OF THE PENUMBRA BOLT 7 AND THE PVASC DEVICE. THIS LARGE CHUNK GOT CAUGHT IN THE PVASC AND SINCE IT WAS SOLID AND MUCH LARGER THAN THE BOLT 7 TIP, THE FRICTION AN FORCE CAUSED THE PVASC TO DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25223015 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A PVASC 6.0X44 EXPANDABLE TIP DETACHED DURING A PROCEDURE WHILE ATTEMPTING TO WITHDRAW THE DEVICE THROUGH A STENTED REGION OF THE BLOOD VESSEL. IT WAS OBSERVED THAT THE EXPANDABLE TIP GOT STUCK ON THE STRUT OF THE STENT. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO WITHDRAW THE DETACHED TIP. HE DECIDED TO COMPRESS THE EXPANDABLE TIP AGAINST THE WALL OF THE ARTERY USING A NEW STENT. FOLLOWING THE DEVICE DETACHMENT AND PLACEMENT OF NEW STENT, THE PATIENT REMAINED CLINICALLY STABLE AND WAS DISCHARGED WITHOUT ANY NEGATIVE AFTER-EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649127 ↗
• MalfunctionMay 5, 2025Solder Joint Fracture; Solder Joint Fracture

  DURING A PROACTIVE OUTREACH TO THE PHYSICIAN, (B)(6) WAS NOTIFIED THAT DURING SURGERY ON WEDNESDAY ((B)(6) 2025), THE PVASC 6.0X44 EXPANDABLE TIP DETACHED FROM THE PUSHER WIRE AND THE EXPANDABLE TIP COULD NOT BE REMOVED. THE PUSHER WIRE WAS REMOVED AND DISCARDED. UPON FOLLOW-UP, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PHYSICIAN: - THE PROCEDURE INVOLVED A CHRONIC ILIAC OCCLUSION. - A 2.7 HEADHUNTER WAS USED THOUGH A BOLT 6 TO DEPLOY THE PVASC DEVICE. - ONCE ENGAGED WITH THE CHRONIC CLOT, AN ATTEMPT WAS MADE TO WITHDRAW THE PVASC DEVICE INTO THE PENUMBRA BOLT 6 CATHETER BY A NON-PHYSICIAN WHILE THE PHYSICIAN WAS NOT SUPERVISING THEM. - THE PRODUCT DETACHED AND THE PHYSICIAN TACKED IT WITH A STENT. THE PHYSICIAN MENTIONED THAT HE PLANNED TO PLACE A STENT IN THE VESSEL ANYWAY. - THE PVASC WIRE WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963422 ↗