Starter™ Guidewire M001492121Recalls & reported problems
Lake Region Medical Limited · Class 2
All models of Starter Guidewire (12)
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 08714729327028), received between Jun 30, 2021 and Jul 27, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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
- Device Contaminated During Manufacture or Shipping1
- No Apparent Adverse Event1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2021No Apparent Adverse Event; No Apparent Adverse Event
PER AI, LOT NUMBER 5999685 AND FOUND A HAIR INSIDE PACKAGE UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12230957 ↗MalfunctionJun 30, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT FOREIGN MATTER WAS IDENTIFIED INSIDE THE PACKAGE. THIS STARTER GUIDEWIRE WAS SELECTED FOR PREPARATION, HOWEVER, UPON OPENING A HAIR WAS FOUND INSIDE THE PACKAGE. IT AS FURTHER REPORTED THAT THIS MEDICAL DEVICE REPORT WAS CREATED AND SUBMITTED IN ERROR AS THIS PRODUCT IS EXTERNALLY MANUFACTURED BY LAKE REGION MEDICAL. THE EXTERNAL MANUFACTURER HOLDS REPORTING RESPONSIBILITIES FOR THIS PRODUCT.
Patient problems: Insufficient Information
MAUDE report 12094105 ↗
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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