ZIPwire™ M00146154B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729763918), received between Aug 12, 2021 and Apr 19, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Material Deformation; Material Deformation

  EVENT DESCRIPTION: THE PHYSICIAN WAS TRYING TO CROSS A VERY CALCIFIED AORTIC BIFURCATION USING AN 035" X 135CM RUBICON AND A ZIPWIRE 260CM. THE PHYSICIAN STATED THAT THE RUBICON WAS KINKING AND UPON REMOVING THE CATHETER IT WAS SLIGHTLY BENT. WHEN THE TECH FLUSH THE RUBICON IT WAS NOTED THAT THERE WERE HOLES IN THE SIDE OF THE CATHETER. WHEN HE REMOVED THE ZIPWIRE HE NOTED THAT THE COATING ON THE TIP OF THE WIRE HAD SHEARED OFF. THE PHYSICIAN CONTINUED WITH THE CASE AND WAS ABLE TO CROSS THE AORTIC BIFURCATION USING A 5FR BERN CATHETER AND A ROSEN, FOLLOWED BY AN AMPLATZ WIRE. HE SUCCESSFULLY PERFORMED ATHERECTOMY USING A 2.5 ROTABLATOR ON THE LESIONS IN THE RIGHT SFA AND FOLLOWED WITH A 5MM X 200MM X 135CM CHARGER BALLOON. IT WAS NOTED AFTER A POST TREATMENT ANGIOGRAM THAT THERE WAS "SOMETHING" IN THE MID SFA. IT WAS PRESUMED TO BE THE COATING TIP OF THE ZIPWIRE SO THE PHYSICIAN DEPLOYED A 6MM X 40MM ELUVIA STENT TO ENSURE THE OBJECT DID NOT TRAVEL AND POSSIBLY EMBOLIZE THE DISTAL ARTERY. THE POST ANGIOGRAM PICTURES CONFIRMED BRISK FLOW THROUGHOUT THE RLE AND THERE WERE NO COMPLICATIONS TO THE PATIENT. AN IMAGE OF THE ZIPWIRE DEVICE WAS PROVIDED. THE FOLLOWING QUESTIONS WERE SUBMI

  Patient problems: Foreign Body In Patient

  MAUDE report 16773129 ↗
• MalfunctionSep 9, 2022Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: MEDICAL REPORT: DURING THE THROMBECTOMY PROCEDURE WITH ANGIOJET SOLENT OMNI 6F, IT WAS NECESSARY TO CHANGE THE CATHETER BECAUSE IT STUCK TO THE ZIPWIRE STANDARD GUIDE WIRE AND IT WAS NOT POSSIBLE TO REMOVE IT WITHOUT EXERTING FORCE AND THIS CAUSED DAMAGE TO THE CATHETER RESULTING IN FAILURE IN USE. AFTER CHANGING THE PROCEDURE, IT FOLLOWED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396238 ↗
• MalfunctionAug 12, 2021Stretched; Material Deformation; Material Integrity Problem; Material Protrusion/Extrusion; Stretched; Material Deformation; Material Integrity Problem; Material Protrusion/Extrusion

  EVENT DESCRIPTION: IT WAS REPORTED THAT: PROCEDURE TYPE: ABDOMINAL ANGIOGRAM. DESCRIPTION OF THE EVENT: THE RUBICON CATHETER TIP BROKE OFF INTO THE PATIENTS AORTA. THE OPERATOR USED A SNARE TO RETRIEVE THE BROKEN CATHETER TIP. THEY WERE ABLE TO SUCCESSFULLY RETRIEVE THE TIP. THE ACCOUNT WOULD LIKE TO KNOW WHY THE RUBICON CATHETER TIP FELL APART THANK YOU THE ZIP WIRE WAS PULLED OUT OF THE CATHETER AND IT APPEARED TO BE FRAYED AND STRINGED OUT/ELONGATED. DEVICES ARE BEING RETURNED AS SOON AS RGA IS AVAILABLE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? THE OPERATOR USED A SNARE TO RETRIEVE THE BROKEN CATHETER TIP. MEDICAL/SURGICAL INTERVENTIONS: SNARED THE DEVICE OUT. PRODUCT - G/WIRE 035/260 ANGLED (BX5), MODEL NUMBER: 46-154B, UPN: M00146154B1, LOT/SERIAL NUMBER: UNKNOWN. WAS THE DEVICE IMPLANTED OR DID AN ATTEMPT TO IMPLANT OCCUR?: NO. FAILURE MODES RELATED TO THIS DEVICE INCLUDE: BENT OR KINKED. WERE THE ISSUES PRESENT UPON OPENING THE PACKAGE?: NO. DO YOU HAVE A PHOTO, VIDEO, OR SCREENSHOT DEPICTING THE ISSUE?: NO.

  Patient problems: Insufficient Information

  MAUDE report 12315996 ↗