ZIPwire™ M0066802080Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00816349011788), received between Jun 15, 2022 and May 4, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjurySep 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER MEDWATCH, IT WAS REPORTED THAT : I NOTED THE FRAGMENT OF GUIDEWIRE COATING IN RENAL PELVIS ATTACHED TO THE PREVIOUSLY PLACED ACCESS NEEDLE. THIS WAS REMOVED UNDER DIRECT VISION BY GRASPING FRAGMENT AND REMOVING IT. NEXT I TURNED ATTENTION TO RENAL PELVIS STONE, THIS WAS EXTRACTED USING THE TRILOGY DEVICE. ONCE ALL THE VISIBLE STONE WAS REMOVED, I AGAIN ENSURED NO FRAGMENTS OF BROKEN WIRE WERE IN COLLECTING SYSTEM AND REMOVED THE ACCESS NEEDLE (BASED ON ENDOSCOPIC EVALUATION WITH RIGID INSTRUMENTS AND FLUOROSCOPY). A 5 FR OPEN ENDED CATHETER WAS THEN PLACED OVER THE SENSOR WIRE AND DOWN URETER. AN 18 FR COUNCIL TIP WAS PLACED INTO RENAL PELVIS OVER THE OTHER WIRE. LOCATION WAS CONFIRMED TO BE IN RENAL PELVIS WITH NEPHROSTOGRAM. THE BALLOON ON CATHETER WAS INFLATED WITH 3 CC AFTER ANTEGRADE NEPHROSTOGRAM CONFIRMED ITS PLACEMENT INTO THE RIGHT RENAL PELVIS. THE SHEATH WAS REMOVED AND CATHETER AND 5 FR WERE SECURED WITH A 0 SILK. THE PATIENT WAS FLIPPED INTO THE SUPINE POSITION HE WAS THEN AWOKEN FROM GENERAL ANESTHETIC WITHOUT INCIDENT, TRANSFERRED TO THE HOSPITAL GURNEY, AND TAKEN FROM THERE TO THE POST-ANESTHESIA CARE UNIT FOR POSTOPERATIVE MONITORING. AT THE

  Patient problems: Foreign Body In Patient

  MAUDE report 20136616 ↗
• InjurySep 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: THE COATING OF THE WIRE-A BLACK PIECE BROKE OFF INSIDE THE KIDNEY AS THEY WERE REMOVING IT OUT. IT APPEARS TO BE LESS THAN 1CM OF A SIZE. THEY ARE STILL CURRENTLY WORKING ON TAKING IT OUT. THERE IS A MALFUNCTION WITH THE DEVICE. THE CUSTOMER SERVICE NUMBER WAS CALLED IMMEDIATELY, AND I WAS REFERRED TO THIS EMAIL. THEY ARE UNABLE TO REMOVE THE ITEM NOW. THIS IS A SERIOUS PATIENT SAFETY ISSUE. ADDITIONAL INFORMATION PROVIDED 28 AUGUST 2024: 1. EVENT DATE - UNKNOWN 2. PATIENT INFORMATION - AGE, WEIGHT, GENDER - UNKNOWN 3. WHAT WAS THE NAME OF THE PROCEDURE(S) PERFORMED? - NEPHROLITHOTOMY 4. WHAT IS THE REASON FOR NO PRODUCT RETURN - DISPOSED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20125744 ↗
• MalfunctionApr 23, 2024Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  EVENT DESCRIPTION: WIRE COATING CAME OFF OF WIRE DURING PROCEDURE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NA . WHAT IS THE NEXT COURSE OF ACTION?: REPLACE . PATIENT PRESENT AT TIME OF EVENT?: YES . PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19167565 ↗
• MalfunctionApr 23, 2024Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  EVENT DESCRIPTION: WIRE COATING CAME OFF OF WIRE DURING PROCEDURE WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NA WHAT IS THE NEXT COURSE OF ACTION?: REPLACE PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166876 ↗
• MalfunctionDec 27, 2022Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE DISTAL 10 CMS OF THE GUIDEWIRE BECAME DETACHED, BUT NOTHING WAS LEFT IN THE PATIENT. THE WIRE BROKE WHEN IT WAS BEING REMOVED. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: N/A. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 21, 2022: 1. WAS THE ZIPWIRE ADVANCED THROUGH A METAL CANNULA OR NEEDLE? NO. 2. WAS THE ZIPWIRE AND COMPANION DEVICE FLUSHED DURING THE PROCEDURE? YES. 3. DID THE PHYSICIAN ENCOUNTER ANY RESISTANCE WHILE REMOVING THE ZIPWIRE? SLIGHT. 4. WHAT METHOD WAS USED TO RETRIEVE THE DETACHED FRAGMENT? A BASKET. 5. HOW WAS THE PROCEDURE COMPLETED? (I.E. WAS THE SAME DEVICE EXCHANGED FOR ANOTHER OF THE SAME, DIFFERENT DEVICE, ETC.)? OPENED ANOTHER OF THE SAME DEVICE. 6. HAS THE DEVICE BEEN REPROCESSED/RESTERILIZED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054658 ↗
• InjuryJun 15, 2022Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: OUR SURGEON WAS PERFORMING A CYSTOSCOPY, LEFT URETEROSCOPY, LASER LITHOTRIPSY, STENT. AT END OF PROCEDURE IT WAS NOTICED ON X-RAY IMAGES THAT A FOREIGN BODY WAS IN THE PATIENTS KIDNEY. SURGEON STATED IT WAS PART OF THE WIRE THAT MUST HAVE BROKE OFF. THE WIRE WAS EXAMINED AND IT APPEARED TO HAVE ONE END THAT WAS NOT NORMAL APPEARING. THE DOCTOR THEN HAD TO REMOVE THE STENT AND GO BACK IN TO RETRIEVE THE BROKEN WIRE. HE WAS ABLE TO SUCCESSFULLY RETRIEVE THE BROKEN PIECE OF WIRE. THE DEFECTIVE ZIPWIRE AND THE PIECE THAT HAD BROKEN OFF THE END WAS COMPARED TO A NEW ZIPWIRE AND IT WAS DETERMINED BY MEASURING THAT THE LENGTHS WERE EQUAL. X-RAY IMAGES WERE CLEAR AND CONFIRMED BY THE DOCTOR. ADDITIONAL INFORMATION RECEIVED 13 JUNE 2022: THE BSC REPRESENTATIVE SPOKE WITH A REPRESENTATIVE AT THE HOSPITAL. HE STATED HE WAS AT THE HOSPITAL THIS MORNING AND SPOKE TO A DOCTOR WHO REPORTED IT WAS A CASE OF THE PHYSICIAN LASERED OFF THE END OF THE GUIDEWIRE BY ACCIDENT. THERE WERE NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14698291 ↗