ZIPwire™ M006630216B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729880783), received between Sep 6, 2018 and Sep 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2018Degraded

  A PATIENT UNDERGOING CENTRAL VENOUS LINE PLACEMENT, VERY DIFFICULT PROCEDURE DUE TO PRIOR CENTRAL VENOUS LINE HISTORY, WITH SHORT BOWEL SYNDROME. DURING THE PROCEDURE, THE LEFT INTERNAL JUGULAR VEIN WAS ACCESSED PERCUTANEOUSLY. DUE TO CENTRAL VENOUS STENOSIS, A ZIPWIRE HYDROPHILIC GUIDEWIRE (150CM STRAIGHT TIP 0.025IN, LOT 10995369) WAS USED. WHILE MANEUVERING THE WIRE, THE COATING OF THE WIRE WAS SHEARED OFF REMAINING WITHIN THE PATIENT. THE BLACK OUTER COATING PEELED OFF AND WAS NOW A FOREIGN BODY WITHIN THE PATIENT. THIS WAS VISUALIZED ON FLUOROSCOPY AND ULTRASOUND TO BE WITHIN THE LEFT INTERNAL JUGULAR VEIN ITSELF. THIS WAS REMOVED ENTIRELY THROUGH AN ALREADY PRESENT INCISION WHICH WAS ENLARGED SLIGHTLY TO ACCOMMODATE RETRIEVAL OF THE FOREIGN BODY. THE FRAGMENT WAS REMOVED ENTIRELY UNDER DIRECT VISUALIZATION. FLUOROSCOPY CONFIRMED COMPLETE REMOVAL. THERE WAS NO BLOOD LOSS OR INJURY TO THE PATIENT ATTRIBUTABLE TO THIS EVENT OTHER THAN ENLARGING SLIGHTLY AN ALREADY PRESENT INCISION MANUFACTURER RESPONSE FOR GUIDEWIRE, ZIPWIRE HYDROPHILIC GUIDEWIRE (PER SITE REPORTER). VOICE MAIL MESSAGE LEFT 5 DAYS LATER FOR LAKE REGION MEDICAL WITH INFORMATION REGARDING SHEARING OF COATING FROM

  Patient problems: No Code Available

  MAUDE report 7850734 ↗