VWING Vascular Needle Guide 00146Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08199260101465), received between Mar 24, 2016 and Jan 14, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryJan 14, 2017Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, DR. (B)(6) REPORTED TO VITAL ACCESS THAT HE HAD SCHEDULED A V WING EXPLANT FOR THAT DAY DUE TO AN INFECTION AT THE V WING SITE. DR. ROSEN SAID THERE WERE NO INDICATIONS OF A SYSTEMIC INFECTION. INITIALLY, SWELLING AT THE SITE WAS THOUGHT TO BE A HEMATOMA BUT THEN IT RUPTURED AND PUSS CAME FROM THE SITE. DR. (B)(6) SAID HE WAS CONSIDERING IMPLANTING A BIOLOGIC GRAFT TO REPLACE THE AVF. PREVIOUS CANNULATIONS, USING BLUNT NEEDLES, HAD BEEN CONSIDERED SUCCESSFUL.

  Patient problems: Fluid Discharge; Rupture; Swelling; Unspecified Infection

  MAUDE report 6252150 ↗
• InjuryMar 24, 2016Insufficient Device Problem Information

  PATIENT KW HAD A SCAB OVER THEIR ARTERIAL ACCESS SITE, WHICH SHOWED PUS ONCE REMOVED. A BLOOD CULTURE WAS (B)(6), BUT A SKIN CULTURE AT THE SITE SHOWED KLEBSIELLA PNEUMONIAE. PATIENT RECEIVED ANTIBIOTICS (ANCEF) BUT REFUSED TO RECEIVE A CENTRAL VENOUS CATHETER DURING HEALING. CANNULATIONS OF THE PATIENT'S FISTULA ARE CONTINUING OUTSIDE OF THE VWING SITES. INITIALLY, THE COMPANY WAS INFORMED THAT THE VWING DEVICES WERE SCHEDULED TO BE REMOVED. UPON SEEING THE PATIENT, THE IMPLANTING SURGEON WAS ABLE TO FURTHER DIAGNOSE THE PATIENT. WHILE THE PATIENT DID HAVE A CANNULATION-RELATED INFECTION, THIS INFECTION WAS DETERMINED TO BE SEPARATE FROM THE VWING DEVICES. THE PATIENT WAS DIAGNOSED WITH AN INFECTED HEMATOMA. THE VWING DEVICES WERE BOTH LEFT IN PLACE IN THE PATIENT WHILE THE HEMATOMA HEALED. THE COMPANY HAS BEEN INFORMED THAT THE PATIENT IS NOW BEING CANNULATED SUCCESSFULLY THROUGH THEIR VWING DEVICES AGAIN. NO VWING-RELATED SERIOUS ADVERSE EVENT OCCURRED.

  Patient problems: Pneumonia; Purulent Discharge

  MAUDE report 5522440 ↗
• InjuryMar 24, 2016Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2016, DR. (B)(6) REMOVED THE VENOUS UPPER PLACED VWING PRODUCT CODE 00146 FROM LOT# 15-0043 FROM PATIENT (B)(6). THIS REMOVAL OF VWING WAS AS A RESULT OF A LOCALIZED INFECTION NOTED AT THE INCISION SITE. WOUND WAS DEBRIDED AND DRAINS PLACED. ARTERIAL VWING WAS NOT TREATED AND IS NOT IN NEED OF INTERVENTION. FOLLOWING REMOVAL, THE INFECTION HAS RESOLVED. THE SOURCE/CAUSE OF INFECTION IS UNKNOWN. THE CURRENT PLAN IS TO IMPLANT A NEW VWING TO ESTABLISH A VENOUS ACCESS SITE. VWINGS WERE INITIALLY IMPLANTED IN (B)(6) ON (B)(6) 2016.

  Patient problems: Unspecified Infection

  MAUDE report 5522354 ↗