ZIPwire™ M006630208B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729764267), received between Jun 15, 2021 and Feb 8, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 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: THE ENTIRE COATING ON THE WIRE CAME OFF AND HAD TO BE TAKEN OUT OF THE PATIENT. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NA. WHAT IS THE NEXT COURSE OF ACTION?: NA. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022: WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. PHOTO OR VIDEO OF ISSUE: NO. HOW WAS THE PROCEDURE COMPLETED (WITH ANOTHER OF THE SAME DEVICE, WITH A DIFFERENT DEVICE, ETC.)? ANOTHER DEVICE. IF THERE WAS A PROCEDURE INVOLVED, WAS IT FOR TREATMENT OR DIAGNOSIS? KIDNEY STONE. IF THERE WAS A PROCEDURE INVOLVED, WHAT WAS THE ANATOMY LOCATION? KIDNEY. WAS THIS THE FIRST TIME THE DEVICE WAS USED (NOT RESTERILIZED OR REPROCESSED)? YES. PLEASE DESCRIBE WHAT PORTION OF THE GUIDEWIRE DETACHED/PEELED HYDROPHILIC TIP, PTFE COATING, OTHER? ENTIRE WIRE COATING CAME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480808 ↗
• MalfunctionFeb 8, 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: DURING THE INSERTION, THE OUTSIDE COATING OF THE WIRE CAME OFF OF THE WIRE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NEW WIRE. WHAT IS THE NEXT COURSE OF ACTION?: REPLACE ALL OF THE OLD PRODUCT CODE ZIP WIRES THEY HAVE ON HAND. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PROCEDURE DATE-UNKNOWN. ADDITIONAL INFORMATION PROVIDED ON JANUARY 25, 2022: WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. PHOTO OR VIDEO OF ISSUE: NO. HOW WAS THE PROCEDURE COMPLETED (WITH ANOTHER OF THE SAME DEVICE, WITH A DIFFERENT DEVICE, ETC.)? ANOTHER WIRE. IF THERE WAS A PROCEDURE INVOLVED, WAS IT FOR TREATMENT OR DIAGNOSIS? KIDNEY STONE. IF THERE WAS A PROCEDURE INVOLVED, WHAT WAS THE ANATOMY LOCATION? KIDNEY. WAS THIS THE FIRST TIME THE DEVICE WAS USED (NOT RESTERILIZED OR REPROCESSED)? YES. PLEASE DESCRIBE WHAT PORTION OF THE GUIDEWIRE DETACHED/PEELED HYDROPHILIC TIP, PTFE COATING, OTHER? ALL OF THE COATING PEELED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480647 ↗
• MalfunctionJun 15, 2021Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device

  EVENT DESCRIPTION: PER MEDWATCH, IT WAS REPORTED THAT: ZIPWIRE GENERAL-PURPOSE NON-VASCULAR GUIDEWIRE WAS BEING USED TO GUIDE INTO THE PATIENT RIGHT URETER FOR A STENT EXCHANGE AND LITHOTRIPSY. THE ZIPWIRE GUIDEWIRE WAS FOUND TO BE SEVERED, CONFIRMED THROUGH FLUOROSCOPY. THE GUIDEWIRE WAS RETRIEVED IMMEDIATELY BY THE SURGEON, AND THE STENT WAS PLACED AS PLANNED. NO HARM TO THE PATIENT WAS IDENTIFIED, ONLY EXTENDING THE LENGTH OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12003943 ↗