ZIPwire™ M00146319B0Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729764175), received between Nov 24, 2021 and Nov 24, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT: TIME OF THE EVENT: DURING THE PROCEDURE. PROCEDURE INFORMATION PROCEDURE TYPE: RIGHT SFA INTERVENTION WHAT CONDITION WAS THE PATIENT BEING TREATED FOR?: PVD. DESCRIPTION OF THE EVENT: PATIENT COMPLICATIONS: DISSECTION. MEDICAL/SURGICAL INTERVENTIONS: PROLONGED BALLOON INFLATION. PATIENT ADMITTED TO HOSPITAL BEYOND STANDARD OF CARE?: YES. DID DEVICE ISSUES CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATIONS? NO. FAILURE MODES RELATED TO THIS DEVICE INCLUDE: NO DEVICE ISSUES. DESCRIBE ANY PATIENT SYMPTOMS THAT OCCURRED RELATED TO THE DISSECTION: WEIGHT BEARING PAIN. WAS THE DISSECTION FLOW LIMITING? YES. WHAT ACTIONS WERE TAKEN AS A RESULT OF THE ISSUE? PROLONGED PTA. WHAT BSC DEVICES WERE USED PRIOR TO DISSECTION? ZIP WIRE. WHAT IS THE ANATOMICAL LOCATION OF THE LESION BEING TREATED? TIBIAL TRUNK. WHAT WAS THE TYPE OF DISSECTION (A-F)? NA. WHAT WAS THE VESSEL LOCATION OF DISSECTION? PERONEAL. WHAT WAS THE PATIENT'S STATUS POST-PROCEDURE? UNKNOWN. ADDITIONAL INFORMATION RECEIVED 18 NOVEMBER 2021: 1. CLARIFICATION NEEDED: DID THE ZIPWIRE HAVE A ROLE IN THE PATIENT COMPLICATIONS? ANS: THE DR. BELIEVES IT WAS AN OPERATOR ERROR AND COMPLEXITY OF THE DISEASE. THE WIRE W
Patient problems: Vascular Dissection
MAUDE report 12870987 ↗
Other Wire, Guide, Catheter devices
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- 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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