ZIPwire™ M006630205B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729761716), received between Jun 12, 2020 and Apr 5, 2023 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2023Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: HELLO, PLEASE SEE COPY OF EMAIL FROM CUSTOMER BELOW - HOPE YOU CAN HELP ME TO FIND OUT WHAT THE ZIP WIRE IS MADE UP OF ? I BELIEVE IT IS CONSTRUCTED FROM A METALLIC CORE WITH OUTER POLYMER COATING. I JUST WANTED TO KNOW WHETHER ITS FLEXIBLE TIP CONTAINED ANY METAL AND IS THERE ANY CONTRAINDICATION FOR THE PATIENT TO UNDERGO MRI IN THE FUTURE AS A PART OF HIS FOLLOW UP TREATMENTS? UNFORTUNATELY, A TINY BIT OF OUTER COATING DISLODGED IN ONE OF OUR PATIENT'S KIDNEYS WHILE WE TRIED TO GET ACCESS TO A PROCEDURE CALLED PCNL. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: UNKNOWN . WHAT IS THE NEXT COURSE OF ACTION?: CUSTOMER WANTS TO KNOW MRI NEEDS TO OCCUR. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO . PATIENT COMPLICATIONS DEVICE ACQUIRED FROM A DISTRIBUTOR?: NO.

  Patient problems: Foreign Body In Patient

  MAUDE report 16683143 ↗
• InjuryJul 13, 2022Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  PER USER MEDWATCH REPORT (B)(4): DESCRIBE THE EVENT OR PROBLEM: THE PATIENT WAS BROUGHT TO THE OR FOR A CYSTO RETROGRADE PYELOGRAM (RPG) LITHOTRIPSY WITH HOLMIUM LASER AND STENT PLACEMENT. TOWARDS THE END OF THE PROCEDURE THE OR TECH NOTICED THAT THE GUIDE WIRE WAS NOT INTACT AND THAT THE "FLOPPY" PORTION OF THE WIRE WAS MISSING. THIS WAS BROUGHT TO THE MDS ATTENTION & THE CIRCULATING NURSE AND THE X-RAY TECH CORROBORATE THIS INTERACTION. THE MD THEN USED THE BROKEN WIRE ON HAND. A POST OP FILM WAS TAKEN, THE PATIENT WENT TO PACU. THE X-RAY TECH SUGGESTED THAT THERE MIGHT BE A PORTION OF WIRE STILL IN THE KIDNEY/URETER. THE DR CONFIRMED THE WIRE WAS STILL RETAINED AND THE PATIENT WAS TAKEN BACK TO THE CYSTO ROOM FOR THE FOREIGN BODY EXTRACTION. DURING THE SECOND PROCEDURE THE WIRE WAS EXTRACTED (A 12" PORTION OF THE 60" ZIPWIRE) AND A NEW STENT WAS INSERTED. THE PATIENT WAS THEN TAKEN BACK TO PACU AND SUBSEQUENTLY DISCHARGED IN GOOD CONDITION. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: CYSTO RPG LITHOTRIPSY WITH HOLMIUM LASAR AND STENT PLACEMENT. ON (B)(6) 2022 OUR DISTRIBUTOR PROVIDED THREE POSSIBLE LOT NUMBERS FOR THE INVOLVED DEVICE AND REQUESTED A DEVICE HISTORY RECORD REVIEW F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008308 ↗
• MalfunctionApr 25, 2022Device Damaged by Another Device; Device Damaged by Another Device

  PER EMAIL, IT WAS REPORTED THAT: SURGEON UTILIZED THIS WIRE TO ASSIST WITH PLACING A RIGHT SUBCLAVIAN INFUSAPORT. IT WAS NOTED BY THE SCRUB TECH THAT THE HYDROPHILIC COATING WAS UNINTENTIONALLY RETAINED IN THE PATIENT. SURGEON WAS ABLE TO RETRIEVE THIS BROKEN OFF PORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193717 ↗
• InjuryNov 10, 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: THE DOCTOR WAS FINISHING UP THE CASE AND WAS PULLING OUT BOTH THE SAFETY WIRE AND WORKING WIRE WHEN IT WAS NOTICED SOME OF THE WIRE FELL OFF IN THE PATIENT. THE DOCTOR THEN USED A 2 PRONG GRASPER TO GO BACK AND GET THE REMAINING WIRE THAT WAS LEFT INSIDE THE PATIENT. WHAT WAS THE OUTCOME OF THE PROCEDURE?: PROCEDURE COMPLETED SUCCESSFULLY. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. WHAT TROUBLESHOOTING STEPS TOOK PLACE? NONE, THIS WAS TOWARDS THE END OF THE CASE SO THE DOCTOR WENT BACK IN AND GRABBED THE REMAINING PORTION OF THE WIRE THAT WAS LEFT BEHIND. DEVICE USED TO COMPLETE PROCEDURE: IT WAS AT THE END OF THE CASE SO ANOTHER WIRE WAS NOT NEEDED. FAILURE MODES RELATED TO THIS DEVICE INCLUDE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. WERE THE ISSUES PRESENT UPON OPENING THE PACKAGE?: NO. HOW WAS THE PROCEDURE COMPLETED (WITH ANOTHER OF THE SAME DEVICE, WITH A DIFFERENT DEVICE, ETC.)? THIS WAS THE END OF THE PROCEDURE SO HE DID NOT NEED ANOTHER WIRE. IF THERE WAS A PROCEDURE INVOLVED, WAS IT FOR TREATMENT OR DIAGNOSIS? TREATMENT. IF THERE WAS A PROCEDURE INVOLVED, WHAT WAS THE ANATOMY LOCATION? URETER AND KIDNEY. WHICH DEVICE WAS USE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790894 ↗
• InjuryApr 22, 2021Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: ON (B)(6) 2021, WE HAD A REPORTABLE EVENT HAPPEN WITH YOUR PRODUCT DEVICE BOSTON SCIENTIFIC ZIP WIRE HYDROPHILIC GUIDEWIRE REF ID (B)(4), LOT NUMBER 11151611, EXP (B)(6) 2022 WHERE THE PATIENT WAS HAVING A POWER PORT PLACEMENT. SURGEON CONFIRMED THE TIP WAS INTACT PRIOR TO INSERTION. HE PRECEDED TO INTRODUCE THE GUIDE WIRE. IT HAS A SMOOTH PLASTIC COATING WHICH DURING ADVANCEMENT SEPARATED FROM THE WIRE AND FRAYED INSIDE THE PATIENT. ONCE THE WIRE WAS REMOVED THE COATING THAT FRAYED OFF WAS RETAINED. THE SURGEON ATTEMPTED TO RETRIEVE THE PIECE BUT WAS UNABLE TO. THE REMOVAL COULD NOT BE DONE IN OUR FACILITY SO THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 11712353 ↗
• InjuryApr 2, 2021Break; Entrapment of Device

  DURING AN ATTEMPTED ULTRASOUND GUIDED PORT PLACEMENT WITH FLOUROSCOPY A PORTION OF THE GUIDEWIRE SHEATH FRAYED AND SEPARATED FROM THE GUIDEWIRE, RESULTING IN A RETAINED SECTION OF THE SHEATH IN THE PATIENT'S JUGULAR VEIN. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11613150 ↗
• MalfunctionDec 17, 2020Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE GUIDEWIRE BROKE IN PATIENT BUT SURGEON WAS ABLE TO RETRIEVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028650 ↗
• MalfunctionSep 15, 2020Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  DR. WAS PERFORMING A RIGHT PERCUTANEOUS NEPHROLITHOTOMY WHEN THE DISTAL TIP OF THE ZIP WIRE BROKE OFF IN THE PATIENT. THE TIP WAS RETRIEVED AND THE PROCEDURE COMPLETED WITH NEW ZIPWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10534411 ↗
• MalfunctionJul 20, 2020Device Damaged by Another Device; Device Damaged by Another Device

  WHEN TRYING TO MODIFY THE LOCATION OF THE PUNCTURE NEEDLE, THE GUIDE DID NOT COME OUT, I HAD TO LOSE ACCESS IN THE CHALICE AND REMOVE THE NEEDLE AND GUIDE, CHANGE IT FOR A SENSOR GUIDE THAT WORKED PERFECTLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10298744 ↗
• MalfunctionJun 12, 2020Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  AT THE TIME OF WANTING TO USE THE GUIDE, THE DOCTOR NOTICED THAT ONE OF THE ENDS HAD NO COATING. SO HE DECIDED NOT TO USE IT ON THE PATIENT AND SUBMIT THE COMPLAINT. ADDITIONALLY IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE (DIFFERENT MODEL).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10148791 ↗