ZIPwire™ M006630209B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729761730), received between Oct 8, 2020 and Dec 17, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2021Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT: PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. FAILURE MODES RELATED TO THIS DEVICE INCLUDE: COATING ISSUE. HOW WAS THE PROCEDURE COMPLETED (WITH ANOTHER OF THE SAME DEVICE, WITH A DIFFERENT DEVICE, ETC.)? COMPLETED WITH SAME DEVICE. ADDITIONAL INFORMATION PROVIDED (B)(6) 2021: FAILURE MODES RELATED TO THIS DEVICE INCLUDE: COATING ISSUE. WERE THE ISSUES PRESENT UPON OPENING THE PACKAGE?: NO DO YOU HAVE A PHOTO, VIDEO, OR SCREENSHOT DEPICTING THE ISSUE?: YES HOW WAS THE PROCEDURE COMPLETED (WITH ANOTHER OF THE SAME DEVICE, WITH A DIFFERENT DEVICE, ETC.)? COMPLETED WITH SAME DEVICE. IF THERE WAS A PROCEDURE INVOLVED, WAS IT FOR TREATMENT OR DIAGNOSIS? TREATMENT IF THERE WAS A PROCEDURE INVOLVED, WHAT WAS THE ANATOMY LOCATION? KIDNEY/URETER WAS THIS THE FIRST TIME THE DEVICE WAS USED (NOT RESTERILIZED OR REPROCESSED)? YES PLEASE DESCRIBE WHAT PORTION OF THE GUIDEWIRE DETACHED/PEELED HYDROPHILIC TIP, PTFE COATING, OTHER?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025536 ↗
• MalfunctionApr 26, 2021Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: THE GUIDEWIRE BROKE DURING A PROCEDURE. A SMALL PIECE OF IT WAS IN THE PATIENT THANKFULLY STAFF WERE ABLE TO GET THE SMALL PIECE OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11726609 ↗
• MalfunctionFeb 22, 2021Device Damaged by Another Device; Device Damaged by Another Device

  THE END OF THE ZIPWIRE WAS TORN AFTER ONE PASS THROUGH OF THE WIRE. THE EVENT OCCURED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER ZIPWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11361150 ↗
• InjuryOct 26, 2020Device Damaged by Another Device; Device Damaged by Another Device

  AFTER COMPLETION OF PROCEDURE THE PATIENT CHEST XRAY WAS ABNORMAL. WHEN THE ZIPWIRE WAS RETRIEVED, INSPECTED, AND COMPARED TO A NEW UNUSED ZIPWIRE IT WAS NOTED THAT A VERY THIN PART OF THE COATING WAS MISSING. PATIENT WAS BROUGHT BACK TO SURGERY TO REMOVE FOREIGN BODY FROM THE GUIDEWIRE THAT WAS SEEN ON POST-OP XRAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10734993 ↗
• InjuryOct 8, 2020Break; Entrapment of Device

  AFTER COMPLETION OF PROCEDURE (INSERTION OF VASCULAR PORT) A CHEST XRAY WAS PERFORMED. RESULTS SUSPECTED RETAINED FOREIGN BODY. THE ZIPWIRE USED IN THE CASE WAS RETRIEVED AND INSPECTED. WHEN COMPARED TO A NEW (UNUSED) ZIPWIRE, IT WAS NOTED THAT A VERY THIN PART OF THE COATING WAS MISSING. THE PATIENT WAS RETURNED TO SURGERY AND AN APPROXIMATELY 15 CM PIECE OF THE GUIDEWIRE WAS RETRIEVED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10657915 ↗