ZIPwire™ M0066802060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816349011764), received between Jan 6, 2023 and May 16, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryMay 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE MATERIALS MANAGER SAID THAT THE ZIPWIRE CAME APART AND SOME SMALL FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE DETAILS AND LOCATION WERE UNCLEAR. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: UNKNOWN. WHAT IS THE NEXT COURSE OF ACTION?: JUST TO DOCUMENT THE SITUATION THE BEST I CAN PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: UNRETRIEVED DEVICE FRAGMENTS (UDF). IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: UNKNOWN. MEDICAL OR SURGICAL INTERVENTIONS: UNKNOWN. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: UNKNOWN. PATIENT OUTCOME: UNKNOWN. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: WHAT WAS THE NAME OF THE PROCEDURE(S) PERFORMED? INSERTION OF VENOUS ACCESS PORT. DID THIS EVENT OCCUR DURING INSERTION, ADVANCEMENT OR WITHDRAWAL? DURING PROCEDURE. (B)(6) 2023, DISTRIBUTOR SENT NOTIFICATION OF AN UPDATE TO THE PATIENT OUTCOME: INSUFFICIENT INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16942477 ↗
• InjuryJan 6, 2023Fracture; Fracture

  EVENT DESCRIPTION: THE DOCTOR WAS GAINING ACCESS TO THE KIDNEY WITH A COOK ACCESS NEEDLE. ONCE IN POSITION HE ASKED FOR THE ZIPWIRE .035 ANGLED TIP. WHILE USING A TORQUE DEVICE THE DOCTOR WAS MANEUVERING THE WIRE TO TRY AND GET IT DOWN THE KIDNEY. WHILE PULLING BACK ON THE WIRE AND ANGLING THE OUTER SHEATH OF THE ACCESS NEEDLE A PART OF THE WIRE WAS SHREDDED OFF/A SMALL PIECE MAY HAVE ALSO BROKEN OFF. IT WAS INITIALLY SEEN UNDER FLUOROSCOPY BUT IT WAS NOT ABLE TO BE LOCATED WITH DIRECT VISION THROUGH A FLEXIBLE CYSTOSCOPE. NEXT STEPS ARE ONGOING. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: OPENED A NEW WIRE AND FINISHED THE CASE. WHAT IS THE NEXT COURSE OF ACTION?: TO BE DETERMINED. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: OTHER. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: UNKNOWN. MEDICAL OR SURGICAL INTERVENTIONS: DOCTOR LOOKED FOR BROKEN PIECE WITH FLEXIBLE CYSTOSCOPE. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: NO. PATIENT OUTCOME: THE ISSUE IS ONGOING. ADDITIONAL INFORMATION PROVIDED ON DECEMBER 30, 2022: WHAT IS THE PATIENT'S CO

  Patient problems: Foreign Body In Patient

  MAUDE report 16112061 ↗