ZIPwireRecalls & reported problems across all models

We found 24 models of ZIPwire by Lake Region Medical in the FDA's device registry (GUDID). Together they are named in 148 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2018 and Sep 18, 2026 — classified as 32 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (83 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ZIPwire problems

ZIPwire models

24 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ZIPwire™ M0066802220

  Stylet, Ureteral
  46 reports
• ZIPwire™ M006630222B0

  Stylet, Ureteral
  21 reports
• ZIPwire™ M00146316B0

  Wire, Guide, Catheter
  11 reports
• ZIPwire™ M006630205B0

  Stylet, Ureteral
  10 reports
• ZIPwire™ M0066802050

  Stylet, Ureteral
  9 reports
• ZIPwire™ M0066802080

  Stylet, Ureteral
  9 reports
• ZIPwire™ M00146151B0

  Wire, Guide, Catheter
  9 reports
• ZIPwire™ M006630209B0

  Stylet, Ureteral
  5 reports
• ZIPwire™ M00146152B0

  Wire, Guide, Catheter
  5 reports
• ZIPwire™ M00146154B0

  Wire, Guide, Catheter
  3 reports
• ZIPwire™ M006630208B0

  Stylet, Ureteral
  3 reports
• ZIPwire™ M0066802060

  Stylet, Ureteral
  2 reports
• ZIPwire™ M0066802230

  Stylet, Ureteral
  2 reports
• ZIPwire™ M0066802160

  Stylet, Ureteral
  2 reports
• ZIPwire™ M00146314B0

  Wire, Guide, Catheter
  2 reports
• ZIPwire™ M0066802210

  Stylet, Ureteral
  1 report
• ZIPwire™ M00146300B0

  Wire, Guide, Catheter
  1 report
• ZIPwire™ M006630206B0

  Stylet, Ureteral
  1 report
• ZIPwire™ M00146165B0

  Wire, Guide, Catheter
  1 report
• ZIPwire™ M00146305B0

  Wire, Guide, Catheter
  1 report
• ZIPwire™ M00146319B0

  Wire, Guide, Catheter
  1 report
• ZIPwire™ M00146236B0

  Wire, Guide, Catheter
  1 report
• ZIPwire™ M006630200B0

  Stylet, Ureteral
  1 report
• ZIPwire™ M006630216B0

  Stylet, Ureteral
  1 report

Recent ZIPwire adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Material Split, Cut or Torn

  Patient problems: Foreign Body In Patient

  MAUDE report 50829082 ↗
• MalfunctionSep 17, 2026Contamination

  Event Description: The nurse took the package with the product they were going to use. Before she opened the package, she noticed a piece of hair inside the package and they took another of the same device for using at the surgery. What troubleshooting steps took place? What troubleshooting steps, if any, resolved the issue?: They used another of the same device. What is the next course of action?: The device will be returned. Patient present at time of event?: Yes Device Acquired from a Distributor?: NoAdditional information from the Distributor:Device 1: UPN M0066802220, Model Number null, Lot or Serial Number JZ10486908If failure mode is 'Other,' details: There was a piece of hair in the packageWas issue present upon opening package?: NoPhoto or video of issue: Yes - I want to upload filesTime of Event: Preparation/Prior to Procedure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806143 ↗
• MalfunctionMay 22, 2026Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: WHEN THE PACKAGE WAS OPENED IN PREPARATION FOR PROCEDURE, IT WAS FOUND THAT THE GUIDEWIRE COATING FELL OFF AND IT COULD NOT BE USED. THE DEVICE IS EXPECTED TO BE RETURNED AROUND MAY. 25TH. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE WHEN WAS THE PROBLEM NOTICED: UNPACKING WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE EVENT RESOLVED? YES. IMAGE PROVIDED (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25258604 ↗
• MalfunctionMay 13, 2026Contamination

  EVENT DESCRIPTION: IT WAS REPORTED THAT: BEFORE THE DEVICE WAS UNPACKED, IT WAS FOUND HAIR INSIDE. THE DEVICE IS EXPECTED TO BE RETURNED AROUND MAY. 14TH. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE . WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE WHEN WAS THE PROBLEM NOTICED: UNPACKING WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: OBSERVATION PATIENT OUTCOME FROM THE EVENT: NONE PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE EVENT RESOLVED? YES PHOTO PROVIDED (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164295 ↗
• InjuryMay 4, 2026Break; Material Split, Cut or Torn

  PER MEDWATCH VOLUNTARY MDR REPORT # MW5185812 RECEIVED 17 APRIL 2026: TIP OF ZIPWIRE BECAME LODGED IN THE PARENCHYMA OF THE PATIENT. INFORMATION SUPPLIED BY DISTRIBUTOR 27 APRIL 2026: PRODUCT AVAILABILITY COMMENT: DEVICE AVAILABLE FOR EVALUATION? YES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25068965 ↗
• MalfunctionApr 27, 2026Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: DURING PREPARATION, WHEN UNPACKING THE PACKAGE, IT WAS FOUND THAT THE URETERAL STENT WAS FRACTURED. THE DEVICE IS EXPECTED TO BE RETURNED AROUND APR 17TH. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. WHEN WAS THE PROBLEM NOTICED: UNPACKING. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. EVENT RESOLVED? YES. DISTRIBUTOR REPORT INDICATED A PHOTO WAS INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008370 ↗
• InjuryMar 24, 2026Break; Material Split, Cut or Torn

  EVENT DESCRIPTION: PROCEDURE WAS PCNL. WIRE BROKE INSIDE PATIENT'S KIDNEY. REP WAS NOT PRESENT DURING TIME OF EVENT. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? ACCORDING TO INFORMATION GIVEN, PHYSICIAN TRIED TO REMOVE BROKEN PIECE OF WIRE WHAT IS THE NEXT COURSE OF ACTION? REPLACED. PRODUCT PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: RENAL/ KIDNEY ISSUES 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 BROKE INSIDE KIDNEY AND PHYSICIAN NEEDED TO RETRIEVE IT. MEDICAL OR SURGICAL INTERVENTIONS: YES. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: UNKNOWN. PATIENT OUTCOME: UNKNOWN. INFORMATION FROM DISTRIBUTOR'S REPORT: WAS ISSUE PRESENT UPON OPENING PACKAGE? NO. IS FUTURE EXPLANT OR REVISION SCHEDULED? UNKNOWN. WHY IS THE DEVICE UNAVAILABLE FOR RETURN? IMPLANTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24681555 ↗
• MalfunctionMar 2, 2026Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: THE HYDROPHILIC COATING WAS FOUND TO BE UNEVEN IN PREPARATION FOR PROCEDURE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. THE DEVICE IS EXPECTED TO BE RETURNED AROUND FEB 25TH. EVENT RESOLVED? YES WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: NONE. ADDITIONAL INFORMATION PROVIDED 10 FEBRUARY 2026: 1. ARE THERE ANY IMAGES AVAILABLE?---SEE THE ATTACHMENT FOR DETAILS 2. WAS THERE VISIBLE DAMAGE TO THE DEVICE AND/OR ITS PACKAGING PRIOR TO USE?---NO 3. PLEASE EXPLAIN WHAT IS MEANT BY "UNEVEN."---THE GUIDEWIRE WAS NOT SMOOTH. A. IS THEIR DAMAGE TO THE BLACK POLYMER JACKET? ---NO B. IS THE METALLIC CORE WIRE EXPOSED? ---NO 4. WERE THERE ISSUES REMOVING THE ZIPWIRE FROM THE PROTECTIVE HOOP?---ENCOUNTERED RESISTANCE AND THE EXTRACTION PROCESS WAS NOT SMOOTH. 5. DID THE END-USER HYDRATE ZIPWIRE PRIOR TO REMOVAL FROM THE PROTECTIVE HOOP?---YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481865 ↗
• MalfunctionFeb 27, 2026Material Deformation

  PER CNF: AFTER UNPACKING, IT WAS FOUND THAT THE TIP OF THE DEVICE WAS BENT. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE EVENT RESOLVED? YES ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: OBSERVATION PATIENT OUTCOME FROM THE EVENT: NONE WHEN WAS THE PROBLEM NOTICED: UNPACKING WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. ADDITIONAL INFORMATION PROVIDED 16 JANUARY 2026: · IS THERE AN IMAGE OF THE REPORTED DEFECT? YES. DID THE END-USER HYDRATE THE WIRE PRIOR TO ATTEMPTING TO REMOVE IT FROM THE DISPENSER HOOP PER THE IFU? THE DEVICE WAS FOUND TO HAVE THE ISSUE BEFORE IT WAS UNPACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474381 ↗
• MalfunctionFeb 24, 2026Material Split, Cut or Torn

  EVENT DESCRIPTION: WHEN THE PHYSICIAN OPENED THE PACKAGE, THE GUIDE WIRE INSIDE WAS FRACTURED BY PULLING, AND THEN THE TIP FELL OFF. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. EVENT RESOLVED: YES. ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: OBSERVATION. PATIENT OUTCOME FROM THE EVENT: NONE. WHEN WAS THE PROBLEM NOTICED: UNPACKING. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429163 ↗
• MalfunctionFeb 6, 2026Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: THE HYDROPHILIC COATING WAS FOUND TO BE CRACKED IN PREPARATION FOR PROCEDURE. THE DEVICE IS EXPECTED TO BE RETURNED AROUND (B)(6). THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. WHEN WAS THE PROBLEM NOTICED: PREPARATION. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. EVENT RESOLVED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280554 ↗
• InjuryFeb 6, 2026Break; Material Split, Cut or Torn

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: THE PROXIMAL END OF THE GUIDEWIRE BROKE WITHIN THE STENT WHILE SLIDING OUT OF THE STENT, WHICH THEN SNAGGED. THE SURGEON CYSTOSCOPICALLY REMOVED BOTH PIECES OF THE GUIDEWIRE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? USED A NEW WIRE WHAT IS THE NEXT COURSE OF ACTION? REPLACE WIRE. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO. PATIENT COMPLICATIONS PATIENT OUTCOME: FULLY RECOVERED TIME OF THE EVENT: DURING PROCEDURE. INDICATE WHICH OF THE FOLLOWING OCCURRED AS A RESULT OF THE PROCEDURE: ALTERNATE DEVICE USED. MEDWATCH REPORT MW5182949 RECEIVED 30 JANUARY 2026. EVENT DESCRIPTION: DURING A SURGICAL UROLOGY PROCEDURE THE PROXIMAL GUIDEWIRE BROKE WITHIN THE URETERAL STENT, WHICH THEN SNAGGED. THE SURGEON CYSTOSCOPICALLY REMOVED BOTH THE STENT AND THE REMAINING GUIDEWIRE PIECE. A NEGATIVE RETROGRADE URETHROGRAM AND DIRECT VISUALIZATION OF NORMAL URETER WAS PERFORMED. A NEW GUIDEWIRE AND STENT WERE THEN PLACED WITHOUT FURTHER EVENT. PT WAS UNDERGOING A URETEROSCOPY WITH LASER LITHOTRIPSY AND DOUBLE J STENT PLACEMENT FOR KIDNEY STONES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278914 ↗
• MalfunctionFeb 5, 2026Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE CUSTOMER WAS USING OUR ZIPWIRE STIFF FOR THE SEMI RIGID URS PROCEDURE WHERE THE PATIENT HAD A URETERAL STONE. WHEN THE SURGEON INSPECTED THE GUIDEWIRE DURING THE PROCEDURE, HE NOTICED THAT THE COATING WAS SCRAPED OFF FROM THE GUIDEWIRE. THEY THEN REMOVED THE GUIDEWIRE AND REPLACED IT WITH ANOTHER OF THE SAME. THE PROCEDURE COULD BE COMPLETED WITHOUT ANY OTHER ISSUES. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? THEY USED ANOTHER OF THE SAME DEVICE. WHAT IS THE NEXT COURSE OF ACTION? THE DEVICE WILL BE RETURNED. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PATIENT OUTCOME: FULLY RECOVERED. DEVICE ACQUIRED FROM A DISTRIBUTOR? NO. WAS ISSUE PRESENT UPON OPENING PACKAGE? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268545 ↗
• MalfunctionFeb 3, 2026Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: THE HYDROPHILIC COATING WAS FOUND TO BE DAMAGED IN PREPARATION FOR PROCEDURE. THE DEVICE IS EXPECTED TO BE RETURNED AROUND (B)(6). THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE PATIENT CONDITION FOLLOWING PROCEDURE - STABLE. WHEN WAS THE PROBLEM NOTICED: PREPARATION. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. EVENT RESOLVED? - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248430 ↗
• MalfunctionFeb 2, 2026No Apparent Adverse Event; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF: AFTER UNPACKING, IT WAS FOUND THAT THE GUIDEWIRE COATING PEELED OFF. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. THE DEVICE IS EXPECTED TO BE RETURNED AROUND (B)(6). WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. EVENT RESOLVED? YES. WHEN WAS THE PROBLEM NOTICED: UNPACKING. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. IMAGE RECEIVED (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239992 ↗

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