ZIPwire™ M0066802050Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00816349011757), received between Feb 18, 2022 and Sep 18, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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.

• InjurySep 18, 2026Material Split, Cut or Torn

  Patient problems: Foreign Body In Patient

  MAUDE report 50829082 ↗
• MalfunctionAug 11, 2025Unsealed Device Packaging; Unsealed Device Packaging

  EVENT DESCRIPTION: AS PREVIOUSLY INFORMED, WE RECEIVED A ZIPWIRE GUIDE WIRE, PART NUMBER M0066802051, LOT JRZ9530806, WHICH ARRIVED OPEN, MAKING IT IMPOSSIBLE TO USE THE PRODUCT. SEE ATTACHED IMAGES FOR A BETTER VIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22774771 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: THIS PACKAGE WAS OPENED AND FOUND WITH THE WIRE OUTSIDE THE COATING. IT IS A ZIPWIRE HYDROPHILIC GUIDEWIRE 150CM 0.035IN; PRODUCT#: M0066802050; LOT#: JRZ9623887 EXPIRES 2028-02-13 IS IT POSSIBLE TO GET CREDIT OR REPLACEMENT SINCE IT IS DEFECTIVE? IMAGE PROVIDED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346919 ↗
• MalfunctionMay 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: AL ABRIR LA GUÍA EL UROLOGO SE DA CUENTA QUE LA PUNTA ESTÁ QUEBRADA Y SE QUEDA ATRAPADA EN EL DISPOSITIVO PLÁSTICO QUE TIENE PARA PROTEGER DICHA PUNTA / WHEN OPENING THE GUIDE, THE UROLOGIST REALIZES THAT THE TIP IS BROKEN AND GETS CAUGHT IN THE PLASTIC DEVICE THAT PROTECTS THE TIP. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? SE REEMPLAZA GUIA / GUIDE IS REPLACED. WHAT IS THE NEXT COURSE OF ACTION? SE CAMBIO LA GUIA Y SE FINALIZO EL PROCEDIMIENTO / THE GUIDE WAS CHANGED AND THE PROCEDURE WAS COMPLETED. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS DEVICE ACQUIRED FROM A DISTRIBUTOR? NO. ADDITIONAL INFORMATION FROM DISTRIBUTOR PROVIDED 29 APRIL 2025: WAS ISSUE PRESENT UPON OPENING PACKAGE? NO. PATIENT NAME-UNKNOWN. BIRTH DATE-UNKNOWN. WEIGHT-UNKNOWN. PATIENT GENDER IDENTITY: UNKNOWN. ADDITIONAL INFORMATION PROVIDED 8 MAY 2025: 1. PLEASE CONFIRM THERE WAS NO CONTACT WITH THE PATIENT. THERE WAS NO CONTACT WITH THE PATIENT. 2. PLEASE DESCRIBE THE PREPARATION STEPS. UNAVAILABLE. A. HOW DID THE END-USER ATTEMPT TO REMOVE THE GUIDEWIRE FROM THE DISPENSER HOOP? UNAVAILABLE. B. WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021724 ↗
• MalfunctionNov 26, 2024Device Damaged by Another Device; Device Damaged by Another Device

  EVENT DESCRIPTION: PHYSICIAN WAS GETTING ACCESS AND USING THE ZIPWIRE THROUGH THE NAVIGUIDE ACCESS NEEDLE. PHYSICIAN BELIEVES THAT THE WIRE GOT PINNED BETWEEN THE STONE AND THE NAVIGUIDE NEEDLE AND WHEN HE WAS PULLING THE WIRE OUT, THE NEEDLE AND STONE COMPRESSED THE WIRE AND SHEERED OFF SOME OF THE WIRE. THERE WERE TWO 'RIBBONS' OF WIRE. PHYSICIAN WAS ABLE TO EXTRACT BOTH PIECES AND WILL RETURN IN PACKAGE WITH DAMAGED WIRE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? NO TROUBLESHOOTING TOOK PLACE. WHAT IS THE NEXT COURSE OF ACTION? REPLACE PRODUCT. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. TIME OF THE EVENT: DURING PROCEDURE. WHAT WAS THE OUTCOME OF THE PROCEDURE? PROCEDURE COMPLETED USING AN ALTERNATE METHOD. ADDITIONAL INFORMATION PROVIDED 26 NOVEMBER 2024: 1. WHAT ARE THE LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC.? NAVIGUIDE NEEDLE M0067001330. 2. IS THE "NAVIGUIDE ACCESS NEEDLE" A METAL NEEDLE? YES, IT IS OUR NEEDLE. 3. THE NARRATIVE INDICATES THAT BOTH PIECES OF THE SHEARED OFF WIRE WERE EXTRACTED. WHAT METHOD WAS USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784870 ↗
• MalfunctionNov 10, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: COMPLAINT: PLASTIC COATING CAME OFF WIRE WHILE IN PATIENT. DOCTOR HAD TO GO BACK IN AND RETRIEVE IT. DOCTOR STARTED INSERTING THE WIRE INTO THE PATIENT. THE WIRE HAD SOME RESISTANCE AT ONE POINT, SO HE PULLED IT BACK AND TRIED TO GUIDE IT IN AGAIN. WHEN IT WOULD NOT GO ALL THE WAY, HE REMOVED THE WIRE TO SEE IF THERE WAS A KINK OR SOMETHING WRONG WITH IT. THAT IS WHEN HE REALIZED THERE WAS COATING ACTUALLY MISSING OFF THE WIRE. HE HAD TO GO BACK IN AND REMOVE THE PIECE OF COATING OUT OF THE PATIENT. AFTER THAT HAPPENED, HE WAS ABLE TO INSERT ANOTHER WIRE AND COMPLETE THE CASE. NO INJURY (OR DEATH) HAPPENED TO THE PATIENT. THERE WAS MINIMAL DELAY IN THE CASE. I HAVE THE DEFECTIVE WIRE AND THE COATING THAT CAME OFF THE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18112204 ↗
• MalfunctionJun 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED: GUIDEWIRE ZIPWIRE HYDROPHILIC 0.035 X 150 STRAIGHT TIP REGULAR SHAFT STIFFNESS - DR WAS TRYING TO SLIDE THE WIRE THROUGH A RIGID URETEROSCOPE AND IT STRIPPED THE COATING OF THE WIRE OFF. ADDITIONAL INFORMATION RECEIVED 13 JUNE 2023: WAS THERE ANY PATIENT INJURY REPORTED? NO. WERE THERE ANY PATIENT COMPLICATIONS DURING THE PROCEDURE(S) OR AFTER AS A RESULT OF THE PRODUCT ISSUE? NONE. PATIENT DETAILS - GENDER, AGE, WEIGHT? NOT APPLICABLE. DID THIS EVENT OCCUR DURING INSERTION, ADVANCEMENT OR WITHDRAWAL? NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. WAS THE GUIDEWIRE HYDRATED OR RINSED WITH SALINE SOLUTION PRIOR TO REMOVAL FROM THE DISPENSER? NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. WAS THERE AN ISSUE WITH LUBRICITY OF THE DEVICE? NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. WAS THE ZIPWIRE FLUSHED DURING THE PROCEDURE? NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. DID ANY PART OF THE GUIDEWIRE DETACH INSIDE THE PATIENT? NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. HOW WAS THE PROCEDURE(S) COMPLETED? (I.E. WAS THE SAME DEVICE EXCHANGED FOR ANOTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210428 ↗
• MalfunctionOct 7, 2022Contamination; Contamination

  EVENT DESCRIPTION: CUSTOMER REPORTS THAT: THE ZIPWIRE GUIDEWIRE MATERIAL SHOWED CONTAMINATION INSIDE THE PACKAGE AT THE TIME OF OPENING. DATE (B)(6)2022. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15565368 ↗
• MalfunctionFeb 18, 2022Device Damaged by Another Device; Device Damaged by Another Device

  A WIRE WAS PUSHED DOWN THROUGH THE COOK CHIBA ACCESS NEEDLE. AFTER MULTIPLE PASSES THE HYDROPHILLIC COATING STARTED TO PEEL BACK AND EVENTUALLY WAS STRIPPED OFF OF THE FIBER AND THE PHYSICIAN HAD TO RETRIEVE THE STRIPPED PIECE. THE PIECE WAS RETRIEVED SUCCESSFULLY. WHAT IS THE NEXT COURSE OF ACTION?: USE THE BSC NAVI GUIDE NEEDLE PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION PROVIDED FEBRUARY 18, 2022: WHAT METHOD WAS USED TO RETRIEVE THE FRAGMENT? BASKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560636 ↗