ZIPwire™ M00146152B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729763901), received between Aug 8, 2022 and Jul 15, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 16, 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.

• InjuryJul 15, 2025Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  EVENT DESCRIPTION: FOLLOWING INSERTION OF THE GUIDEWIRE THROUGH THE ENTRY NEEDLE, DUE TO HEAVY CALCIFICATION ON THE VESSEL, WHILE THE PHYSICIAN MANIPULATED THE GUIDEWIRE TO PROMOTE IT, HE RETRACTED THROUGH THE NEEDLE EDGE AND A PIECE OF THE TIP COATING PEELED OFF THE WIRE AND STUCK ON THE PLAQUE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: AS THE PIECE OF COATING WAS STUCK ON THE VESSEL PLAQUE AND NOT IN THE LUMEN/CIRCULATION, THERE WAS NO ATTEMPT TO CONTINUE. THEY STOPPED THE PROCEDURE. WHAT IS THE NEXT COURSE OF ACTION?: SURVEILLANCE. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. REASON FOR UNSUCCESSFUL PROCEDURE: INABILITY TO PROCEED WITH GUIDEWIRE PLACEMENT DEVICE ACQUIRED FROM A DISTRIBUTOR?: NO. ADDITIONAL INFORMATION AND IMAGE FROM THE DISTRIBUTOR PROVIDED 26 JUNE 2026: PROCEDURE: LOWER LIMP REVASCULARISATION. WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. WAS IT CONFIRMED THAT NO COATING/WIRE FRAGMENTS WERE LEFT INSIDE THE PATIENT? THERE WAS A PIECE LEFT IN AS DESCRIBED IN THE PREVIOUS SECTION. WHERE ON THE WIRE DID THE COATING COME OFF? TIP, DISTAL 12CM. PICTURE ATTACHED AS WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22507076 ↗
• MalfunctionMay 23, 2023Unsealed Device Packaging; Unsealed Device Packaging

  EVENT DESCRIPTION: IT WAS REPORTED THAT AFTER UNPACKING, IT WAS NOTED THAT THE ASEPTIC PACKAGE OF THE GUIDEWIRE WAS NOT SEALED. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE MAY 31ST. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986997 ↗
• MalfunctionOct 13, 2022Fracture; Fracture

  EVENT DESCRIPTION: IT WAS REPORTED THAT WHEN THE PHYSICIAN OPENING THE PACKAGE, IT WAS FOUND THAT THE HYDROPHILIC COATING AT THE TIP OF THE GUIDEWIRE WAS NOT COMPLETELY COVERED, SO THE PHYSICIAN REPLACED IT WITH A NEW GUIDEWIRE FOR USE. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE AUG.8TH. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597616 ↗
• MalfunctionAug 26, 2022Unsealed Device Packaging; Unsealed Device Packaging

  EVENT DESCRIPTION: RT/SUPPLY COORDINTOR WAS RESTOCKING HER PROCEDURE ROOMS AFTER CASES. SHE WAS GOING TO PUT AWAY THE ZIP WIRE THAT SHE HAD JUST REMOVED FROM THE BOX. WHEN SHE WENT TO HANG TO THE PACKAGE ON ITS HOOK THE WIRE FELL OUT BECAUSE THE PACKAGE WAS OPEN. PATIENT PRESENT AT TIME OF EVENT?: NO. PATIENT COMPLICATIONS: NO. PATIENT COMPLICATIONS REASON FOR UNSUCCESSFUL PROCEDURE: NA. WAS THE PATIENT SEDATED WHEN THE PROCEDURE WAS CANCELLED?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15304838 ↗
• InjuryAug 8, 2022Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  AS REPORTED,: ATTEMPTING TO GET MORE INFORMATION FROM REPORTER SO FAR THIS IS ALL THE INFORMATION I HAVE BEEN GIVEN: GUIDEWIRE WAS INSERTED INTO PATIENT TO GUIDE IMPLANTS IN. WHEN REMOVING THE GUIDEWIRE, THE PLASTIC COAT ON THE GUIDEWIRE WAS STRIPPED OFF AND A PORTION WAS LEFT INSIDE THE PATIENT. SURGEON ATTEMPTED TO RETRIEVE FOREIGN OBJECT BUT COULD NOT. PATIENT COMPLICATIONS: UN-RETRIEVED DEVICE FRAGMENT. WHAT TROUBLESHOOTING STEPS TOOK PLACE? IF ANY, WHAT TROUBLESHOOTING STEPS RESOLVED THE ISSUE? UNKNOWN. WHAT IS THE NEXT COURSE OF ACTION? UNKNOWN. MEDICAL/SURGICAL INTERVENTIONS: UNKNOWN. PATIENT OUTCOME: UNKNOWN. PATIENT ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE?: UNKNOWN. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CONTRIBUTE TO THE PATIENT COMPLICATION(S)? UNKNOWN. ADDITIONAL INFORMATION SUPPLIED ON AUGUST 3, 2022: WHEN IN THE PROCEDURE DID THE ISSUE OCCUR? DURING THE MIDDLE OF THE PROCEDURE. WHAT WAS THE NAME OF THE PROCEDURE(S) PERFORMED? LASER LEAD EXTRACTION, INSERTION OF NEW ELECTRONIC LEADS. HOW WAS THE PROCEDURE(S) COMPLETED? (I.E. WAS THE SAME DEVICE EXCHANGED FOR ANOTHER OF THE SAME, DIFFERENT DEVICE, ETC.)? ANOTHER DEVICE WAS USED TO COMPLETE THE PROC

  Patient problems: Foreign Body In Patient

  MAUDE report 15182234 ↗