ZIPwire™ M0066802230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816349011832), received between Jun 30, 2023 and Mar 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Device Damaged by Another Device; Material Deformation; Material Split, Cut or Torn; Device Damaged by Another Device; Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: DURING PCNL COATING CAME OFF WIRE AND IN PATIENT. MD WAS ABLE TO RETRIEVE RETAINED WIRE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? N/A. WHAT IS THE NEXT COURSE OF ACTION? WIRE REPLACED. 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 DEVICE. IMAGES RECEIVED 17 MARCH 2025. ADDITIONAL INFORMATION PROVIDED 24 MARCH 2025: 1. LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. NEPHROSCOPE, UNSURE OF MANUFACTURER. 2. WAS THE ZIPWIRE ADVANCED THROUGH A METAL CANNULA OR NEEDLE? NEPHROSCOPE SHEATH. 3. DID THIS EVENT OCCUR DURING INSERTION, ADVANCEMENT, OR WITHDRAWAL? ONGOING USE. 4. DID THE PHYSICIAN ENCOUNTER ANY RESISTANCE WHILE INSERTING, ADVANCING, OR REMOVING THE ZIPWIRE? UNKNOWN. 5. WHAT METHOD WAS USED TO RETRIEVE THE "RETAINED WIRE"? UNKNOWN. 6. ARE THERE EFFORTS TO OBTAIN THE LOT NUMBER FOR THE COMPLAINT DEVICE? YES, SENT PACKAGING BACK WITH RETURN. 7. WHAT IS THE ANATOMY LOCATION OF THE DEVICE? KIDNEY/URET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688077 ↗
• MalfunctionJun 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  PER MEDWATCH, IT WAS REPORTED THAT: SAFETY WIRE WAS REMOVED. INSPECTION OF GLIDEWIRE AT THE END OF THE CASE SHOWED 2 MILLIMETER(S) (MM) TIP OF GLIDEWIRE BROKE OFF. NOTE FROM DISTRIBUTOR RECEIVED (B)(6), 2023: WE WILL NOT BE ABLE TO SEND A FOLLOW UP ON THIS COMPLAINT SINCE INITIAL REPORTER AND HEALTH CARE FACILITY ARE UNKNOWN. THE DEVICE IS RETURNING; HOWEVER, IT HAS NOT BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 17239266 ↗