ZIPwire™ M006630222B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729764274), received between Jun 18, 2020 and Jan 2, 2025 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER NMPA, IT WAS REPORTED THAT: THE PATIENT UNDERWENT URETERAL CALCULI PROCEDURE UNDER COMBINED SPINAL AND EPIDURAL ANESTHESIA ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS FOUND THAT THE HYDROPHILIC GUIDE WIRE TIP WAS RUPTURED AND THE INNER WIRE WAS EXPOSED ANALYSIS OF CAUSE OF THE EVENT: PRODUCT REASONS(INCLUDING MANUALS) PROCEDURE OUTCOME: THE HYDROPHILIC GUIDE WIRE WAS REPLACED AND THE PROCEDURE WAS CONTINUED MALFUNCTION: DURING THE PROCEDURE, IT WAS FOUND THAT THE HYDROPHILIC GUIDE WIRE TIP WAS RUPTURED AND THE INNER WIRE WAS EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060501 ↗
• MalfunctionJun 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: THE PATIENT UNDERWENT URETEROSCOPIC STENT REPLACEMENT PROCEDURE. WHEN THE GUIDE WIRE WAS USED DURING THE PROCEURE, THE PHYSICIAN FELT THAT THERE WAS RESISTANCE. AFTER WITHDRAWING THE GUIDE WIRE, THE OUTER MEMBRANE WAS FOUND TO BE FOLDED AND HAVE SOME SMALL DEFECTS. AFTER VERIFICATION AND COMPARISON BY THE NURSE, THE PHYSICIAN IMMEDIATELY REMOVED THE URETEROSCOPE FOR FLUSHING, REMOVED THE SMALL OUTER MEMBRANE FROM THE URETEROSCOPE WORKING CHANNEL, AND REPLACED THE GUIDE WIRE. ANALYSIS OF CAUSE OF THE EVENT: PRODUCT REASONS(INCLUDING MANUALS) ANALYSIS DESCRIPTION OF CAUSE OF THE EVENT: THE PATIENT UNDERWENT URETEROSCOPIC STENT REPLACEMENT PROCEDURE. WHEN THE GUIDE WIRE WAS USED DURING THE PROCEURE, THE PHYSICIAN FELT THAT THERE WAS RESISTANCE. AFTER WITHDRAWING THE GUIDE WIRE, THE OUTER MEMBRANE WAS FOUND TO BE FOLDED AND HAVE SOME SMALL DEFECTS. AFTER VERIFICATION AND COMPARISON BY THE NURSE, THE PHYSICIAN IMMEDIATELY REMOVED THE URETEROSCOPE FOR FLUSHING, REMOVED THE SMALL OUTER MEMBRANE FROM THE URETEROSCOPE WORKING CHANNEL, AND REPLACED THE GUIDE WIRE. THE PRODUCT WAS DEFECTIVE. PROCEDURE OUTCOME: THE PHYSICIAN REPLACED IT WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617994 ↗
• MalfunctionSep 23, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE USED DURING THE PREPARATION. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE JULY 1ST. THERE WERE NO PATIENT COMPLICATIONS REPORTED. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE EVENT RESOLVED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15471670 ↗
• MalfunctionSep 22, 2022Device Damaged by Another Device; Material Integrity Problem; Material Split, Cut or Torn; Device Damaged by Another Device; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TIP OF GUIDE WIRE HAD NO SUPPORT FORCE. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE (B)(6). THERE WERE NO PATIENT COMPLICATIONS REPORTED. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. EVENT RESOLVED? YES. ADDITIONAL INFORMATION AND AN IMAGE OF THE DEVICE WERE PROVIDED ON (B)(6) 2022: IT POSSIBLY BE THAT THE COATING OF THE TIP OF GUIDEWIRE FELL OFF DURING THE USE OF THE GUIDE WIRE, RESULTING IN POOR OR NO SUPPORT FORCE OF THE GUIDE WIRE HEAD END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462526 ↗
• InjuryMar 10, 2022Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: IT WAS REPORTED THAT: USED DURING A PERCUTANEOUS NEPHROSTOMY, THE DISTAL END OF THE GUIDE DETERIORATED INTO MINI-FILAMENTS, A PIECE OF WHICH REMAINED INSIDE THE PATIENT'S KIDNEY (VISIBLE ON THE X-RAY). CLINICAL CONSEQUENCES: A GUIDEWIRE FILAMENT REMAINED INSIDE THE PATIENT'S KIDNEY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13724938 ↗
• MalfunctionFeb 14, 2022Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED AFTER UNPACKING. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE FEB. 8TH. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IS CLINICAL? NO. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. WAS THE PROBLEM ASSOCIATED WITH LABELED USE? YES. EVENT RESOLVED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524719 ↗
• MalfunctionFeb 1, 2022Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PTFE PEELED OFF. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE FEB 10TH. IS CLINICAL? NO. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. WHERE DID THE PROBLEM OCCUR? INSIDE THE PATIENT. EVENT RESOLVED? YES. ADDITIONAL INFORMATION RECEIVED JANUARY 25, 2022: 1. WAS THERE ANY PATIENT INJURY REPORTED? NO. 2. WAS IT THE FIRST TIME THE DEVICE WAS USED? IF NOT, HOW MANY TIMES HAD IT BEEN? YES. 3. WAS THERE VISIBLE DAMAGE TO THE DEVICE AND/OR ITS PACKAGING PRIOR TO USE? EXCEPT REPORTED, NO. 4. HOW WAS THE PROCEDURE(S) COMPLETED? (I.E. WAS THE SAME DEVICE EXCHANGED FOR ANOTHER OF THE SAME, DIFFERENT DEVICE, ETC.)? COMPLETED WITH ANOTHER OF THE SAME DEVICE. 5. DID THIS EVENT OCCUR DURING INSERTION, ADVANCEMENT OR WITHDRAWAL? DURING PROCEDURE. 6. DID ANY PART OF THE GUIDEWIRE DETACH INSIDE THE PATIENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415430 ↗
• MalfunctionNov 10, 2021Device Handling Problem; Device Handling Problem

  EVENT DESCRIPTION: IT WAS REPORTED THAT DURING PREPARATION, IT WAS FOUND THE INNER CORE WAS EXPOSED, IT COULD NOT BE USED. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE NOV.9TH. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IS CLINICAL? NO. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. WHERE DID THE PROBLEM OCCUR? INSIDE THE PATIENT. WAS THE PROBLEM ASSOCIATED WITH LABELED USED? YES. ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: NONE. PATIENT OUTCOME FROM THE EVENT: NONE. EVENT RESOLVED? YES. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 1, 2021: THE COMPLAINT NARRATIVE STATES THE ISSUE WAS FOUND DURING PREPARATION; HOWEVER, THE NARRATIVE ALSO INDICATES THAT THE WIRE WAS INSIDE THE PATIENT. PLEASE PROVIDE CLARIFICATION. WAS IT THE FIRST TIME THE DEVICE WAS USED? IF NOT, HOW MANY TIMES HAD IT BEEN? YES. WAS THERE VISIBLE DAMAGE TO THE DEVICE AND/OR ITS PACKAGING PRIOR TO USE? YES. IF DAMAGE WAS NOTED, WHERE ON THE WIRE WAS THE DAMAGE? ONLY KNEW IT WAS ON THE WIRE. WAS THE SPECIMEN PROPERLY PREPARED FOR USE? NO. WAS THE DISPENSER ASSEMBLY INJECTED WITH ENOUGH PHYSIOLOGICAL SALINE TO COMPLETELY WET THE SPECIMEN WIRE BEFORE REMOVING IT FROM THE DISPENSER ASSEMBL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788160 ↗
• InjuryOct 19, 2021Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  EVENT DESCRIPTION: IT WAS REPORTED THAT: WE HAD A STIFF ZIPWIRE THAT BROKE WHILE BEING USED IN A PATIENT. THEY WERE ABLE TO GET THE BROKEN PIECE OUT AND USE ANOTHER ONE BUT WANTED TO REPORT IT TO SOMEONE. I DO HAVE THE ITEM IN MY OFFICE IN A BIOHAZARD BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12660960 ↗
• MalfunctionJul 22, 2021Material Integrity Problem; Material Integrity Problem

  EVENT DESCRIPTION: IT WAS REPORTED THAT UPON UNPACKING THE PACKAGE AND PREPARING FOR THE PROCEDURE, IT WAS FOUND THE GUIDEWIRE PEELED OFF, SO IT COULD NOT BE USED NORMALLY. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE JUL. 13TH. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211829 ↗
• MalfunctionJun 28, 2021Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: IT WAS REPORTED THE DOCTOR WAS USING THE ZIP SUPER STIFF GUIDEWIRE TO GET ACCESS AND THE COATING OF THE WIRE PEELED BACK. THE SAME ISSUE HAPPENED TO ANOTHER DOCTOR WHEN USING A SCOPE. THESE DOCTORS ARE EXTREMELY UPSET ABOUT THE COATING COMING OFF THE WIRE THAT THEY WANT TO CHANGE WIRES TO SOMETHING ELSE. - DEVICE ISSUES OR PATIENT COMPLICATIONS? ONLY DEVICE PERFORMANCE ISSUE(S) - WHAT TROUBLESHOOTING STEPS TOOK PLACE? N/A - WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? WHAT IS THE NEXT COURSE OF ACTION? N/A. ADDITIONAL EVENT INFORMATION PROVIDED ON (B)(6) 2021: WAS THERE VISIBLE DAMAGE TO THE DEVICE AND/OR ITS PACKAGING PRIOR TO USE? I WAS NOT THERE FOR THE CASE, BUT TO THE BEST OF THE KNOWLEDGE THERE WAS NO DAMAGE TO THE DEVICE OR THE PACKAGING PRIOR TO USE. WHAT IS MEANT BY "THE COATING OF THE WIRE PEELED BACK"? IS THE METAL CORE WIRE EXPOSED? WHAT I MEAN BY THAT IS THE COATING PEALED OFF THE WIRE AND THE WIRE WAS EXPOSED. PLEASE SEE PICTURE ATTACHED. DID THIS EVENT OCCUR DURING INSERTION, ADVANCEMENT OR WITHDRAWAL? ADVANCEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076122 ↗
• MalfunctionJun 24, 2021Device Damaged by Another Device; Device Damaged by Another Device

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO ZIPWIRE DEVICES USED DURING THIS PROCEDURE. MEDWATCH REPORT 2126666-2021-00021 CAPTURES THE SECOND DEVICE. EVENT DESCRIPTION: IT WAS REPORTED THAT: THE DOCTOR WAS USING A FLEXIBLE URETEROSCOPE AND PLACED THE STIFF ZIP WIRE DOWN THE WORKING CHANNEL AND WHEN THE DOCTOR WAS PULLING OUT THE ZIP WIRE THE COATING OF THE WIRE PEELED AWAY. THE DOCTOR DECIDED TO OPEN UP A SENSOR WIRE AND USE THIS INSTEAD AND THIS SOLVED THE ISSUE. - DEVICE ISSUES OR PATIENT COMPLICATIONS? ONLY DEVICE PERFORMANCE ISSUE(S) - WHAT TROUBLESHOOTING STEPS TOOK PLACE? THEY TRIED ANOTHER ZIP WIRE AND THE COATING STARTING TO PEEL AWAY. - WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? WHAT IS THE NEXT COURSE OF ACTION? THEY SWITCHED TO SENSOR WIRE AND THERE WERE NO ISSUES. ADDITIONAL EVENT INFORMATION PROVIDED ON 22JUN2021: THE COMPLAINT NARRATIVE INDICATES "THE COATING OF THE WIRE PEELED AWAY". ARE THEY TALKING ABOUT THE BLACK POLYMER JACKET MATERIAL? YES. DID ANY OF THE "COATING" DETACH? IF SO, WHAT EFFORTS WERE MADE TO RECOVER IT? YES, THE COATING DETACHED INTO THE PATIENT AND THE PHYSICIAN HAD TO GO IN WITH A BASKET TO GET THE MATERIAL OUT. WAS THE GUIDEWIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12062755 ↗
• MalfunctionJun 24, 2021Device Damaged by Another Device; Device Damaged by Another Device

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO ZIPWIRE DEVICES USED DURING THIS PROCEDURE. MEDWATCH REPORT 2126666-2021-00020 CAPTURES THE FIRST DEVICE. EVENT DESCRIPTION: IT WAS REPORTED THAT: THE DOCTOR WAS USING A FLEXIBLE URETEROSCOPE AND PLACED THE STIFF ZIP WIRE DOWN THE WORKING CHANNEL AND WHEN THE DOCTOR WAS PULLING OUT THE ZIP WIRE THE COATING OF THE WIRE PEELED AWAY. THE DOCTOR DECIDED TO OPEN UP A SENSOR WIRE AND USE THIS INSTEAD AND THIS SOLVED THE ISSUE. - DEVICE ISSUES OR PATIENT COMPLICATIONS? ONLY DEVICE PERFORMANCE ISSUE(S) - WHAT TROUBLESHOOTING STEPS TOOK PLACE? THEY TRIED ANOTHER ZIP WIRE AND THE COATING STARTING TO PEEL AWAY. - WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? WHAT IS THE NEXT COURSE OF ACTION? THEY SWITCHED TO SENSOR WIRE AND THERE WERE NO ISSUES. DEVICE 2 OF 2. ADDITIONAL EVENT INFORMATION PROVIDED ON (B)(6) 2021: THE COMPLAINT NARRATIVE INDICATES "THE COATING OF THE WIRE PEELED AWAY". ARE THEY TALKING ABOUT THE BLACK POLYMER JACKET MATERIAL? YES. DID ANY OF THE "COATING" DETACH? IF SO, WHAT EFFORTS WERE MADE TO RECOVER IT? YES, THE COATING DETACHED INTO THE PATIENT AND THE PHYSICIAN HAD TO GO IN WITH A BASKET TO GET THE MATERIAL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12062728 ↗
• MalfunctionApr 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO URETERAL CALCULUS. AT 9PM, DJ CATHETER PLACEMENT WAS NEEDED UNDER GUIDANCE OF A HYDROPHILIC GUIDEWIRE. THE PHYSICIAN UNPACKED THE GUIDEWIRE AND FOUND ONE END OF THE HYDROPHILIC GUIDEWIRE HAD NO HYDROPHILIC LAYER, AND THE INNER METAL LAYER OF THE GUIDEWIRE WAS EXPOSED. THE PHYSICIAN STOPPED USING THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDEWIRE AND THE PHYSICIAN REPORTED THE ISSUE TO HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716382 ↗
• MalfunctionMar 26, 2021Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: COATING ON GUIDEWIRE CAME OFF INSIDE PATIENT. PHYSICIAN WAS ABLE TO THOROUGHLY IRRIGATE PATIENT TO REMOVE LOST COATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11578368 ↗
• MalfunctionMar 17, 2021Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT: THE HYDROPLUS COATING IS MISSING 3 CM. THE ISSUE WAS REPORTED TO HAVE OCCURED OUTSIDE THE PATIENT DURING PREPARATION OF THE WIRE. ADDITIONAL INFORMATION RECEIVED ON MARCH 17, 2021, REPORTED THAT THE ZIPWIRE WERE USED TOGETHER WITH A CYSTOSCOPE. DURING THE INSERTION THE DOCTOR NOTICED THAT THE POLYMER JACKET MATERIAL WAS MISSING. THE PROCEDURE WAS COMPLETED WITH A NEW ZIPWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507518 ↗
• MalfunctionFeb 10, 2021Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: COATING WAS COMING OFF THE WIRE DURING URETEROSCOPY PROCEDURE IN URETER. ANOTHER WIRE OF THE SAME KIND WAS USED TO COMPLETE THE CASE. NO PATIENT CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11310687 ↗
• InjurySep 18, 2020Device Damaged by Another Device; Insufficient Device Problem Information; Device Damaged by Another Device; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR ON (B)(6) 2020 REPORTING THAT THE MENTIONED PRODUCT IS INDEED A ZIPWIRE EVEN THOUGH THEY MENTION A TERUMO GUIDE. IT WAS ALSO REPORTED THAT PART OF THE DISTAL COVER OF THE WIRE STAYED IN THE KIDNEY. ON (B)(6)\ 2020, IT WAS REPORTED THAT THERE WAS NO DATE PROVIDED FROM THE HOSPITAL REGARDING AN ADDITIONAL PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10553319 ↗
• InjuryAug 25, 2020Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT: TESTIMONY OF THE NURSE OF THE OPERATING ROOM: AN URO ZIPWIRE STIFF HYDROLIC GUIDEWARE USED DURING A NEPHROSTOMY ON THE RIGHT SIDE WAS STRIPPED AND A PART OF THIS GUIDE (THE BLACK PART, THE SHEATH) WAS THORN AND IT REMAINED IN THE OPERATING ROOM. PLACE OF THE EVENT: OPERATING ROOM. CLINICAL CONSEQUENCES: SERIOUS. CONSERVATIVE MEASURES AND ACTIONS TAKEN: FUTURE URETEROSCOPY IN ORDER TO REMOVE THE FOREIGN BODY. AS PER EMAIL: WE HAVE KEPT THE DEVICE IN QUESTION. YOU CAN SEE A PART OF THE SHEATH WAS THORN. WE CAN SEE ALSO ON RADIOGRAPHY, THE PART OF THE GUIDE THAT COULD NOT BE REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10448798 ↗
• MalfunctionJun 24, 2020Device Damaged by Another Device; Material Deformation; Material Integrity Problem; Device Damaged by Another Device; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE PTFE PEELED OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PROBLEM OCCURED INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10188597 ↗
• MalfunctionJun 18, 2020Device Damaged by Another Device; Material Integrity Problem; Device Damaged by Another Device; Material Integrity Problem

  COATING PEELED OFF WHILE IN URETEROSCOPE AND WAS RETRIEVED FROM THE URETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10168113 ↗