ZIPwire™ M00146314B0Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729764120), received between Mar 2, 2022 and Mar 2, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Damaged by Another Device2
- Material Split, Cut or Torn2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2022Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn
NOTE: THIS REPORT IS BEING FILED TO CAPTURE THE SECOND WIRE USED IN THE PROCEDURE: "CUSTOMER GRABBED ANOTHER WIRE FROM SAME BATCH AND EVENT HAPPENED AGAIN." MEDWATCH REPORT 9680001-2022-00102 CAPTURES THE FIRST DEVICE. EVENT DESCRIPTION: CUSTOMER WAS PERFORMING A ROUTINE CATHETER EXCHANGE AND NOTICED THAT THE HYDROPHILIC COATING OF THE WIRE WAS SHEARED OFF. CUSTOMER GRABBED ANOTHER WIRE FROM SAME BATCH AND EVENT HAPPENED AGAIN. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: REPLACEMENT WIRE PULLED. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13652523 ↗MalfunctionMar 2, 2022Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn
THIS REPORT PERTAINS TO THE FIRST OF TWO ZIPWIRE DEVICES USED DURING THE PROCEDURE. MEDWATCH REPORT 9680001-2022-00103 CAPTURES THE SECOND DEVICE REFERRED TO IN THE COMPLAINT NARRATIVE, "CUSTOMER GRABBED ANOTHER WIRE FROM SAME BATCH AND EVENT HAPPENED AGAIN." EVENT DESCRIPTION: CUSTOMER WAS PERFORMING A ROUTINE CATHETER EXCHANGE AND NOTICED THAT THE HYDROPHILIC COATING OF THE WIRE WAS SHEARED OFF. CUSTOMER GRABBED ANOTHER WIRE FROM SAME BATCH AND EVENT HAPPENED AGAIN. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: REPLACEMENT WIRE PULLED. PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS CUSTOMER SUPPLIED AN IMAGE ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13652434 ↗
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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