ZIPwire™ M00146151B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729763895), received between Mar 27, 2021 and Oct 21, 2024 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PRODUCT ISSUE: GUIDWIRE WAS DAMAGED WHEN THE OPERATOR TRIED TO CROSS THE LESION. PATIENT STATUS: NO ADVERSE PATIENT EFFECTS DESCRIBE THE EVENT IN DETAIL INCLUDING THE REPORTED CLINICAL OBSERVATIONS, WHERE/WHEN EVENT OCCURRED, TROUBLESHOOTING RESULTS, DEVICE/LEAD MEASUREMENTS, ADVERSE PATIENT EFFECTS, AND PATIENT OUTCOME: THE CONSULTANT TRIED TO CROSS A SIGNIFICANT LESION IN THE VEIN ACCESS DURING THE BEGINNING OF THE PROCEDURE. ADDITIONAL COMMENTS 1: BECAUSE THE SEVERITY WAS CONSIDERED, THE CONSULTANT ASKED FOR AN HIDROPHILIC GUIDE WIRE. I HAVE GIVEN A 0.35 GUIDE WIRE - ZIP ADDITIONAL COMMENTS 2: THE CONSULTANT TRIED TO CROSS THE LESION BUT THE WIRE WAS COMPLETELY DAMAGED. IMAGES AND ADDITIONAL INFORMATION PROVIDED ON 16 OCTOBER 2024: AS I HAVE MENTIONED ON THE PER, THIS HIDROPHILIC GUIDE WIRE (0.35 ZIP WIRE) WAS DAMAGED WHEN THE CONSULTANT WAS TRYING TO CROSS THE LESION IN ONE OF THE VENOUS ACCESS. AND THERE WAS NO ADVERSE PATIENT EFFECTS. BECAUSE OF THE SEVERITY OF THIS OBSTRUCTION, THE CONSULTANT ASKED FOR THIS HIDROPHILIC GUIDE WIRE. AFTER A SEVERAL TRIES, IT WAS REPORTED THAT THERE'S WAS RESISTANCE AND THIS GUIDE WIRE APPEARED TO BE DAMAGED. THIS ISSUE HAPPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495320 ↗
• InjuryJul 19, 2023Device 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: ELDERLY MALE WITH HISTORY OF PVC (PREMATURE VASCULAR CONTRACTION). PROCEDURE: ELECTROPHYSIOLOGY STUDY WITH ABLATION. WIRE WAS INTRODUCED INTO PATIENT'S LEFT FEMORAL ARTERY THROUGH A COOK NEEDLE. WHEN REMOVING WIRE THROUGH NEEDLE A PIECE OF THE HYDROPHILIC COATING SHEARED OFF ON THE TIP OF THE NEEDLE. THE COATING APPEARS TO BE LODGED IN SOFT TISSUE UNDER THE SKIN BASED ON FLUOROSCOPY. OBSERVED OVERNIGHT AND DISCHARGED THE NEXT DAY WITH DECREASE IN PVCS. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

  Patient problems: Foreign Body In Patient

  MAUDE report 17351174 ↗
• InjuryJun 16, 2022Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  PER USER MEDWATCH REPORT 3600840000-2022-8050: ELDERLY MALE WITH HISTORY OF ATRIAL FIBRILLATION, CHRONIC HEART FAILURE, ELEVATED BLOOD PRESSURE AND LOW HEART RATE. PROCEDURE: PERMANENT PACEMAKER PLACEMENT. PROBLEM; WHILE IN THE LEFT SUBCLAVIAN VEIN, THE ZIPWIRE DELAMINATED INSIDE THE VESSEL. THE REMAINING WIRE WAS SUCCESSFULLY RETRIEVED BY THE PHYSICIAN AT THE TIME OF THE INCIDENT. NO IDENTIFIED HARM, ANTICIPATED DISCHARGE IN 2 DAYS. NO ADDITIONAL SURGERY NEEDED, OBSERVED IN SAME DAY, OVERNIGHT FOR OBSERVATION MANUFACTURER RESPONSE FOR WIRE, GUIDE, CATHETER, ZIPWIRE¿ (PER SITE REPORTER) WILL OBTAIN WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PROCEDURE: PERMANENT PACEMAKER PLACEMENT. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14716291 ↗
• MalfunctionJun 8, 2022Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6), WHEN THE GUIDE WIRE WAS USED FOR ANGIOGRAPHY, IT COULD NOT BE DELIVERED INTO THE ANGIOGRAPHY CATHETER NORMALLY. AFTER EXAMINATION, THE PHYSICIAN FOUND THAT THE TIP OF THE GUIDE WIRE WAS BIFURCATED AND COULD NOT BE USED NORMALLY. THE PHYSICIAN REPLACED A NEW GUIDE WIRE AS SOON AS THE PHYSICIAN FOUND THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634636 ↗
• InjuryMay 31, 2022Peeled/Delaminated

  ELDERLY MALE WITH HISTORY OF ATRIAL FIBRILLATION, CHRONIC HEART FAILURE, ELEVATED BLOOD PRESSURE AND LOW HEART RATE. PROCEDURE: PERMANENT PACEMAKER PLACEMENT. PROBLEM; WHILE IN THE LEFT SUBCLAVIAN VEIN, THE ZIPWIRE DELAMINATED INSIDE THE VESSEL. THE REMAINING WIRE WAS SUCCESSFULLY RETRIEVED BY THE PHYSICIAN AT THE TIME OF THE INCIDENT. NO IDENTIFIED HARM, ANTICIPATED DISCHARGE IN 2 DAYS. NO ADDITIONAL SURGERY NEEDED, OBSERVED IN SAME DAY, OVERNIGHT FOR OBSERVATION. MANUFACTURER RESPONSE FOR WIRE, GUIDE, CATHETER, ZIPWIRE¿ (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14546867 ↗
• MalfunctionJan 31, 2022Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: PLEASE PROVIDE A BRIEF SUMMARY OF THE EVENT THAT INCLUDES ANY ADDITIONAL DETAILS THAT YOU HAVE NOT ALREADY PROVIDED: WASN'T THERE FOR PROCEDURE. PROCEDURE COMPLETED WITH ANOTHER WIRE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NONE. WHAT IS THE NEXT COURSE OF ACTION?: SEND THEM ANOTHER BOX. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PROCEDURE DATE: UNKNOWN. ADDITIONAL INFORMATION: WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. PHOTO OR VIDEO OF ISSUE: YES. QUESTION: HOW WAS THE PROCEDURE COMPLETED (WITH ANOTHER OF THE SAME DEVICE, WITH A DIFFERENT DEVICE, ETC.)? ANSWER: ANOTHER WIRE. IF THERE WAS A PROCEDURE INVOLVED, WAS IT FOR TREATMENT OR DIAGNOSIS? ANSWER: UNKNOWN. QUESTION: IF THERE WAS A PROCEDURE INVOLVED, WHAT WAS THE ANATOMY LOCATION? ANSWER: UNKNOWN. QUESTION: WAS THIS THE FIRST TIME THE DEVICE WAS USED (NOT RESTERILIZED OR REPROCESSED)? ANSWER: YES. QUESTION: WHICH DEVICE WAS USED WITH THE WIRE WHEN THE ISSUE WAS FOUND? ANSWER: UNKNOWN. QUESTION: WAS THE PROBLEM FOUND DURING INSERTION OR RETRACTION OF THE WIRE? ANSWER: UNKNOWN. QUESTION: HOW MANY DEVICE EXC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13400060 ↗
• InjuryJan 18, 2022Fracture; Fracture

  EVENT DESCRIPTION: PLEASE PROVIDE A BRIEF SUMMARY OF THE EVENT THAT INCLUDES ANY ADDITIONAL DETAILS THAT YOU HAVE NOT ALREADY PROVIDED: DIALYSIS CATHETER EXCHANGE WAS PROCEDURE, THEY ADVANCED THE WIRE THROUGH OLD CATHETER, THEN REMOVED OLD CATHETER. PLACED NEW CATHETER OVER THAT WIRE. WHEN CATHETER WAS SECURED IN BODY THEY WENT TO REMOVE WIRE AND IT FRACTURED APPROXIMATELY HALFWAY DOWN THE WIRE SHAFT. AT THAT POINT THEY TRIED TO SNARE WIRE OUT BUT COULDN'T. PATIENT WAS TRANSFERRED TO OUTSIDE FACILITY WHERE WIRE WAS SUCCESSFULLY REMOVED ENDOVASCULAR METHOD. UNKNOWN OUTSIDE LOCATION AT THIS TIME. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: ATTEMPTED TO REMOVE WIRE PER NORMAL PROCEDURE. WHAT IS THE NEXT COURSE OF ACTION?: N/A. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: ADDITIONAL INTERVENTION REQUIRED. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: YES. PLEASE DESCRIBE THE WAY IN WHICH THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATION?: WIRE COULDN'T BE REMOVED AND PATIENT TRANSFERRED TO OUTSIDE FACILITY TO HANDLE. MEDICAL OR SURGIC

  Patient problems: Insufficient Information

  MAUDE report 13283257 ↗
• MalfunctionJul 9, 2021Defective Device; Material Deformation; Material Integrity Problem; Material Protrusion/Extrusion; Defective Device; Material Deformation; Material Integrity Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT: THE PHYSICIAN USED THE M00146151B1 GUIDEWIRE DURING THE PROCEDURE, IT WAS FOUND THE TIP OF THE CLEAR WATER COATING WAS BIFURCATED WHEN OPENED THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE DEVICE IS EXPECTED TO BE RETURNED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION RECEIVED JUNE 17, 2021: PLEASE CLARIFY WHAT IS MEANT BY "THE TIP OF THE CLEAR WATER COATING WAS BIFURCATED". THE TIP COATING OF THE CATHETER WAS CRACKED. WAS THERE VISIBLE DAMAGE TO THE DEVICE AND/OR ITS PACKAGING PRIOR TO USE? THE TIP COATING OF THE CATHETER WAS CRACKED. IS THERE DAMAGE TO THE BLACK POLYMER JACKET MATERIAL? YES. IS THE METALLIC CORE WIRE EXPOSED? NO. WAS THE GUIDEWIRE HYDRATED OR RINSED WITH SALINE SOLUTION PRIOR TO REMOVAL FROM THE DISPENSER? YES. IS THERE AN IMAGE AVAILABLE? NO. ADDITIONAL INFORMATION RECEIVED JUNE 21, 2021: 1. WAS THE DAMAGE TO THE GUIDEWIRE RATHER THAN THE CATHETER? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142682 ↗
• InjuryMar 27, 2021Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: THIS PIECE OF GUIDEWIRE GOT STUCK IN A PATIENT DURING SURGERY. ADDITIONAL INFORMATION FROM WIP REPORT: COMPLAINT SUMMARY: IT WAS REPORTED THAT UNRETRIEVED DEVICE FRAGMENT OCCURRED. A 035/150 ZIPWIRE (ZIPWIRE HYDROPHILIC GUIDE WIRE) WAS ADVANCED FOR TREATMENT. HOWEVER, DURING SURGERY, PIECE OF THE GUIDEWIRE WAS STUCK IN THE PATIENT. NO FURTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION RECEIVED AT A LATER DATE STATED: "A PIECE OF GUIDEWIRE GOT STUCK IN A PATIENT DURING SURGERY AND WE HAVE THAT PIECE HERE AND IT NEEDS TO BE SENT OFF FOR INVESTIGATION."

  Patient problems: Insufficient Information

  MAUDE report 11579881 ↗