ZIPwire™ M0066802160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816349011948), received between Nov 17, 2022 and Jan 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2025Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: FROM CUSTOMER, " WE USE THE ZIP WIRES IN THE VASCULAR SURGERY PRACTICE AND THE ONE WE USED TODAY WAS DEFECTIVE. THE SHEATH DETACHED FROM ITSELF AND SLID DOWN THE WIRE, WHICH WOULD HAVE BEEN A HUGE CONCERN IF IT DETACHED COMPLETELY IN THE PATIENTS VEIN." WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: UNAVAILABLE WHAT IS THE NEXT COURSE OF ACTION?: UKN PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS TIME OF THE EVENT: DURING PROCEDURE. ADDITIONAL INFORMATION PROVIDED 8 JANUARY 2025: 1. WHAT WAS THE NAME OF THE PROCEDURE(S) PERFORMED? RADIOFREQUENCY ABLATION. 2. IS THERE A PHOTO OF THE COMPLAINT DEVICE? A PICTURE HAS BEEN ATTACHED TO THIS EMAIL. 3. WHAT WAS THE OUTCOME OF THE PROCEDURE (COMPLETED WITH THIS DEVICE, COMPLETED WITH ANOTHER OF THE SAME DEVICE, COMPLETED WITH A DIFFERENT DEVICE, ETC.)? COMPLETED WITH THIS DEVICE; DEFECT WAS NOTICED UPON REMOVING THE DEVICE FROM THE PATIENT. 4. WHAT WAS THE PATIENT OUTCOME FOLLOWING THE PROCEDURE (GOOD, STABLE ETC.)? GOOD. 5. WHAT WAS THE ANATOMY LOCATION OF THE DEVICE? LOWER EXTREMITY 6. WAS THE ZIPWIRE ADVANCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106991 ↗
• MalfunctionNov 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: WE RECEIVED A PRODUCT FAILURE RECENTLY OF A GUIDEWIRE BREAKING DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15816445 ↗