ZIPwire™ M00146316B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729764144), received between Jul 22, 2020 and Sep 24, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024No Apparent Adverse Event; Material Split, Cut or Torn; No Apparent Adverse Event; Material Split, Cut or Torn

  USING PROCESS: IT WAS REPORTED THAT ON (B)(6) 2024, THE GUIDE WIRE WAS PRE-USED TO SUPPORT CATHETER TO CROSS THE SUBCUTANEOUS TISSUE, IT WAS FOUND THAT THE GUIDE WIRE PEELED OFF, AND IT COULD NOT BE USED. IT WAS IMMEDIATELY STOPPED USING, AND IT WAS REPLACED WITH OTHER GUIDE WIRE TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT ANALYSIS DESCRIPTION OF CAUSE OF THE EVENT: THE GUIDE WIRE WAS PRE-USED TO SUPPORT CATHETER TO CROSS THE SUBCUTANEOUS TISSUE, IT WAS FOUND THAT THE GUIDE WIRE PEELED OFF, AND IT COULD NOT BE USED. THE PRODUCT QUALITY PROBLEM WAS NOT EXCLUDED. PROCEDURE OUTCOME: IT WAS IMMEDIATELY STOPPED USING, AND IT WAS REPLACED WITH OTHER GUIDE WIRE TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION PROVIDED 18 SEPTEMBER 2024: PLEASE FURTHER CLARIFY WHAT WAS MEANT BY "THE GUIDE WIRE WAS PRE-USED". DURING NORMAL USE OF THE GUIDEWIRE. WAS THE WIRE RE-STERILIZED (RE-PROCESSED)? NO. WAS THIS THE FIRST TIME THE WIRE WAS USED? YES. KINDLY PROVIDE LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. BSC: EXTRACTOR PRO XL: M00547100; BSC- FLEXIMA: M00539220; MICROPORT-GUIDEWIRE FOR BILIARY TRACT: MTN-89/45-A. PLEASE CLARIFY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294888 ↗
• MalfunctionMay 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: THEY WERE DOING A RECANALIZATION OF THE AFS AND WERE INSERTING THE ZIPWIRE INTO THE PATIENT. HE DID A MILD ROTATION OF THE WIRE TO TRY TO PASS THE MILD CALCIFICATION IN THE AFS, AND THEN THE COATING OF THE ZIPWIRE 'BROKE' OUTSIDE THE PATIENT AT THE LEVEL OF THE HANDS OF THE PHYSICIAN. HE TOOK THE WIRE OUT AND TOOK A NEW ZIPWIRE AND COULD PROCEED WITH THE PROCEDURE. PATIENT WAS OKEY. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: HE REMOVED THE WIRE FROM THE PATIENT, AND TOOK ANOTHER ZIPWIRE TO COMPLETE THE PROCEDURE WHAT IS THE NEXT COURSE OF ACTION?: INVESTIGATE THIS WIRE PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS DEVICE ACQUIRED FROM A DISTRIBUTOR?: NO WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO PHOTO OR VIDEO OF ISSUE: YES QUESTION: WAS THE VESSEL CALCIFIED? MILD, MODERATE OR SEVERE? ANSWER: MILD CALCIFIED QUESTION: WAS THE VESSEL TORTUOUS? MILD, MODERATE OR SEVERE? ANSWER: MILD QUESTION: WHAT WAS THE PERCENT STENOSIS OF THE LESION? ANSWER: 70% QUESTION: WHAT IS THE ANATOMICAL LOCATION OF THE LESION BEING TREATED? ANSWER: AFS AT THE RIGHT QUESTION: WHAT DEVICE WAS USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229248 ↗
• MalfunctionSep 12, 2023Device 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 THE GUIDEWIRE ENTERED THE INTESTINE, THE TIP FELL OFF WITHOUT CROSSING THE LESION, AND THE COATING REMAINED IN THE PATIENT'S BODY, AND THEN THE TIP WAS REMOVED BY SNARE. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE SEP. 13TH. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ALL ADDITIONAL INFORMATION BELOW WAS PROVIDED TO THE MANUFACTURER 4 SEPTEMBER 2023: 28-AUGUST-2023 1. PER EVENT DESCRIPTION, "THE GUIDEWIRE ENTERED THE INTESTINE, THE TIP FELL OFF WITHOUT CROSSING THE LESION, AND THE COATING REMAINED IN THE PATIENT'S BODY". PLEASE VERIFY THE FOLLOWING QUESTIONS. A. WAS IT A PARTIAL OR A COMPLETE SEPARATION? COMPLETE SEPARATION B. WAS IT A WIRE SEPARATION OR WAS IT THE BLACK POLYMER SLEEVE SECTION THAT PEELED OFF THE WIRE? THE BLACK POLYMER SLEEVE SECTION C. WHAT INTERVENTION WAS DONE BY THE PHYSICIAN WHEN THE GUIDEWIRE ENTERED THE INTESTINE? THE PHYSICIAN OPERATED THE GUIDEWIRE NORMALLY, AND THERE WAS NO PROBLEM WITH PROFICIENCY D. WHAT WAS THE PHYSICIAN'S ASSESSMENT TO FOR THE COATING REMAINED IN THE PATIENT'S BODY? COLONOSCOPE AND ENDOSCOPIC BIOPSY FORCEPS WERE USED TO REMOVE 2. IF AVAILABLE, PLEASE PROVIDE LESION CHARACTERISTICS: A. % OF S

  Patient problems: Foreign Body In Patient

  MAUDE report 17732258 ↗
• MalfunctionJun 1, 2023Material Protrusion/Extrusion; Material Split, Cut or Torn; Material Protrusion/Extrusion; Material Split, Cut or Torn

  EVENT DESCRIPTION: IT WAS REPORTED THAT AFTER UNPACKING THE TIP OF THE DEVICE WAS PROTRUDING. THE DEVICE IS EXPECTED TO BE RETURNED BEFORE JUNE 2ND. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION RECEIVED ON MAY 25, 2023: 1. WAS THERE VISIBLE DAMAGE TO THE DEVICE AND/OR ITS PACKAGING PRIOR TO PREPARATION FOR USE? NO 2. WAS THE GUIDEWIRE HYDRATED OR RINSED WITH SALINE SOLUTION PRIOR TO REMOVAL FROM THE DISPENSER? THE PROBLEM WAS FOUND BEFORE THE GUIDEWIRE WAS REMOVED FROM THE DISPENSER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037771 ↗
• MalfunctionJan 12, 2023Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  EVENT DESCRIPTION: ZIPWIRE COATING WAS STICKY THROUGHOUT THE CASE PER THE TECH, AND PHYSICIAN. UPON ADVANCING RUBICON OVER ZIPWIRE PAST TIBIAL LESION. THE ZIPWIRE WAS BEING REMOVED TO ADVANCE A ROTA WIRE IN ITS PLACE TO PERFORM TIBIAL ATHERECTOMY. THE ZIPWIRE DID NOT WANT TO COME OUT OF THE RUBICON. AFTER SOME FIRM TENSION FROM DOCTOR THE ZIPWIRE WAS FINALLY REMOVED WITH THE PROXIMAL PORTION OF THE WIRE APPEARING STRETCHED AND COATING HAD SEPARATED AS WELL. A NEGATIVE WAS PULLED ON THE RUBICON WITH A FLUSH SYRINGE WHICH SHOWED NO COATING IN THE SYRINGE. EXTENSIVE FLUORO OF THE EXTREMITY WAS PERFORMED TO MAKE SURE NO PORTIONS OF THE WIRE REMAINED THOUGH IT APPEARED INTACT UPON REMOVAL. AFTER THIS THE PROCEDURE WAS COMPLETED SUCCESSFULLY PERFORMING ROTABLATION AND BALLOON ANGIOPLASTY. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: N\A. WHAT IS THE NET COURSE OF ACTION?: N\A. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: - WAS THIS THE FIRST TIME THE DEVICE WAS USED (NOT RESTERILIZED OR REPROCESSED)? YES, THIS WAS THE FIRST TIME THE WIRE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16147515 ↗
• MalfunctionNov 17, 2022Material Integrity Problem; Material Integrity Problem

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: WE HAVE USED ZIPWIRE STIFF 260CM WITH THE GUIDANCE & RUBICON CATHETER TO PASS A LESION IN FEMORAL LOOP GRAFT, THERE WAS AN ABNORMALITY NOTICED IN THE WIRE BECOME EXPOSED FROM THE OUTER LAYER WHICH HINDER ITS UNSAFE IN THE OPERATION & BECOME MALFUNCTION , SO USAGE OF ANOTHER ONE WIRE WAS A MUST. ADDITIONAL INFORMATION RECEIVED NOVEMBER 14, 2022: 1. PER EVENT, "THERE WAS AN ABNORMALITY NOTICED IN THE WIRE BECOME EXPOSED FROM THE OUTER LAYER WHICH HINDER ITS UNSAFE IN THE OPERATION". PLEASE CLARIFY IF THE COATING OF THE WIRE WAS PEELED OFF? OR JUST UNRAVELLED? NO, THERE WAS NOT AN ABNORMALITY NOTICED IN THE WIRE(JUST UNRAVELLED). 2. WHEN WAS THE ISSUE NOTED? (DURING PROCEDURE, PREPARATION, ETC) PLEASE SPECIFY. DURING PROCEDURE. 3. HOW WAS THE PROCEDURE COMPLETED (WITH ANOTHER OF SAME DEVICE, WITH A DIFFERENT DEVICE, ETC.)? PLEASE SPECIFY. WITH A DIFFERENT DEVICE. 4. WHAT WAS THE PATIENT'S CONDITION POST PROCEDURE? (STABLE, FINE GOOD, ETC) GOOD. 5. PLEASE PROVIDE LESION CHARACTERISTICS: TORTUOSITY? (NOT TORTUOUS, MILD, MODERATE, SEVERE) MILD TORTUOSITY. THE FOLLOWING CHARACTERISTICS WERE REQUESTED, BUT NOT PROVIDED: % STENOSIS, CALCIFIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815726 ↗
• MalfunctionJan 24, 2022Material Integrity Problem; Material Integrity Problem

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: INJURY TYPE: OTHER DURING THE PROCEDURE, IT WAS FOUND THAT THE TIP OF THE GUIDE WIRE WAS PEELING OFF, IMMEDIATELY REPLACED WITH A NEW GUIDE WIRE, THE PATIENT CONTINUED TREATMENT. COMPLAINT SUMMARY: IT WAS REPORTED THAT THE GUIDEWIRE TIP SEPARATION OCCURRED. A GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS FOUND THAT THE TIP OF THE GUIDE WIRE WAS PEELING OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. ADDITIONAL INFORMATION RECEIVED JANUARY 18, 2022: WHAT WAS THE NAME OF THE PROCEDURE(S) PERFORMED? ONLY KNEW THE PROCEDURE IS FOR ANGIOGRAPHY. WAS IT THE FIRST TIME THE DEVICE WAS USED? YES. WAS THERE VISIBLE DAMAGE TO THE DEVICE AND/OR ITS PACKAGING PRIOR TO USE? YES ANY RESISTANCE FELT DURING INSERTION? NO. WAS THE CATHETER STUCK/LOCKED ON THE GUIDEWIRE? NO OR WAS THERE JUST SIGNIFICANT RESISTANCE BETWEEN THE DEVICES (NOT STUCK)? NO. WAS THE GUIDEWIRE HYDRATED OR RINSED WITH SALINE SOLUTION PRIOR TO REMOVAL FROM THE DISPENSER? YES. WAS THERE AN ISSUE WITH LUBRICITY OF THE DEVICE? YES. DID THE PHYSICIAN ENCOUNTER ANY RESISTANCE WHILE ADVANCING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13337096 ↗
• MalfunctionDec 7, 2021Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PATIENT OUTCOME: EXPECTED TO FULLY RECOVER DID DEVICE ISSUES CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATIONS? NO. ADDITIONAL INFORMATION: "THE HYDROPHILIC COATING OF THE GUIDEWIRE WAS DAMAGED AND IT GOT STUCKED INSIDE A RUBICON 35 (SUPPORT CATHETER)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954088 ↗
• MalfunctionAug 18, 2021Material Deformation; Material Integrity Problem; Material Protrusion/Extrusion; Material Deformation; Material Integrity Problem; Material Protrusion/Extrusion

  EVENT DESCRIPTION: IT WAS REPORTED THAT: DESCRIPTION OF THE EVENT: PHYSICIAN FELT THAT THE WIRE DIDN'T FEEL RIGHT - SHE REMOVED IT. WHAT TROUBLESHOOTING STEPS TOOK PLACE? NONE - WIRE FELT FUNNY TO THE PHYSICIAN SO SHE REMOVED IT. TIME OF THE EVENT: DURING INSERTION. PROCEDURE TYPE: ANGIOGRAM. WHAT CONDITION WAS THE PATIENT BEING TREATED FOR?: PAD. WHAT WAS THE OUTCOME OF THE PROCEDURE?: PROCEDURE COMPLETED SUCCESSFULLY. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. DEVICE USED TO COMPLETE PROCEDURE: ANOTHER ZIP WIRE. FAILURE MODES RELATED TO THIS DEVICE INCLUDE: BREAK/FRACTURED. WERE THE ISSUES PRESENT UPON OPENING THE PACKAGE?: NO. DO YOU HAVE A PHOTO, VIDEO, OR SCREENSHOT DEPICTING THE ISSUE?: YES. WAS THE DEVICE REMOVED FROM THE PATIENT INTACT/FRACTURED POST PROCEDURE? INTACT. WHAT IS THE ANATOMICAL LOCATION OF THE LESION BEING TREATED? SFA. WHEN DURING THE PROCEDURE DID THE DEVICE FRACTURE (UNPACKING, PREPARATION, INTRODUCTION, USE, REMOVAL, PACKAGING FOR SHIPMENT, ETC)? INTRODUCTION. IMAGE PROVIDED ON AUGUST 10, 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337786 ↗
• MalfunctionAug 16, 2021Entrapment of Device; Device Damaged by Another Device; Material Split, Cut or Torn; Entrapment of Device; Device Damaged by Another Device; Material Split, Cut or Torn

  EVENT DESCRIPTION: DURING THE USE OF THE ANGIOJET CATHETER AND ONE OF THE STIFF GUIDE WIRES, SERUM LEAKAGE WAS OBSERVED THROUGH THE CATHETER BODY (EXTRA BODY), WHICH PREVENTED US FROM CONTINUING TO USE THE UNIT (LOT - 26858297), WE NOTICED THAT THE LEAKAGE OCCURRED AFTER LOSS OF HYDROPHILICITY OF THE GUIDE, AND WHEN IT WAS PASSED FOR REMOVAL AND REPLACEMENT OF THE SET, THE WIRE GOT STUCK IN THE REGION OF LEAKAGE AND DEGLOVING OF THE HYDROPHILIC COVER OF THE GUIDE (WHICH NO LONGER HAD HYDROPHILICITY) (LOT - JRZ5799152). "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324453 ↗
• MalfunctionJul 22, 2020Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT CATHETER STUCK ON GUIDEWIRE OCCURRED. AFTER A ZIPWIRE HYDROPHILIC GUIDE WIRE WAS INSERTED, AN ANGIOJET SOLENT OMNI WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER BECAME STUCK ON THE ZIPWIRE WHILE INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308797 ↗