ZIPwire™ M00146300B0Recalls & reported problems
Lake Region Medical · Class 2
All models of ZIPwire (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729761013), received between Oct 4, 2023 and Oct 4, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT DESCRIPTION: THE PRODUCT WAS USED IN A PROCEDURE WHERE LARGE PARTS OF THE TEFLON WERE LEFT INSIDE THE CATHETER AFTERWARDS. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NO. WHAT IS THE NEXT COURSE OF ACTION?: REPLACE THE PRODUCT FOR THE CUSTOMER PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO. PATIENT COMPLICATIONS DEVICE ACQUIRED FROM A DISTRIBUTOR?: NO. ADDITIONAL QUESTIONS SUBMITTED BY DISTRIBUTOR: WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. PHOTO OR VIDEO OF ISSUE: YES. WHAT IS THE ANATOMICAL LOCATION OF THE LESION BEING TREATED? NA. WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE? NA. ADDITIONAL INFORMATION PROVIDED BY DISTRIBUTOR ON (B)(6) 2023: THIS WAS AN ABSCESS DRAINAGE. AN AMPLATZ WIRE WAS INITIALLY USED, BUT THIS BENT DUE TO THE CATHETER INSERTION (12F PIGTAIL (ARGON)). THEREFORE SWITCHED TO ZIP-WIRE, WHERE THE PIGTAIL CATHETER WAS SUCCESSFULLY INSERTED, BUT WHEN THE MANDREL WAS TO BE REMOVED IT GOT STUCK IN THE CATHETER. WHEN I REACHED IN AND PULLED IT OUT, THE CORE CAME OUT, WHILE THE TEFLON COATING REMAINED INSIDE THE CATHETER. THE CATHETER WAS REMOVED WITH THE TEFLON COATING INSIDE. IT IS X-RA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17870977 ↗
Other Wire, Guide, Catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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