Jetstream™ Jetwire 011525-000Recalls & reported problems
Lake Region Medical · Class 2
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 08714729888772), received between Jun 22, 2020 and Jul 13, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2022Material Integrity Problem; Material Integrity Problem
EVENT DESCRIPTION: MATERIAL WAS DEFECTIVE. THE GUIDEWIRE THAT WAS ROUTED WITH THE CATHETER WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15006765 ↗MalfunctionJun 22, 2020Entrapment of Device; Entrapment of Device
WHEN USING THE JETSTREAM 2.4 CATHETER, IT WAS DIFFICULT TO REMOVE THE WIRE, BEING LOCKED. THE ENTIRE SYSTEM WAS REMOVED AND THE JETWIRE WIRE STILL WOULDN'T COME OFF. TO COMPLETE THE PROCEDURE, IT WAS NECESSARY TO USE ANOTHER JETSTREAM 2.1 CATHETER. IN THE FIRST PASS OF THE WIRE, IT DID NOT PRESENT ANY RESISTANCE, IN THE SECOND TIME A GREATER RESISTANCE WAS PERCEIVED IN LOWERING THE CATHETER BY THE WIRE AND FOR THAT REASON THE PROCEDURE WITH JETSTREAM 2.1 WAS NOT CONCLUDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10178799 ↗
Other Wire, Guide, Catheter devices
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- 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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