Starter™ Guidewire M001491381Recalls & reported problems
Lake Region Medical Limited · "J" Curved Moveable Core Guidewire · Class 2
All models of Starter Guidewire (12)
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 08714729326632), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
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.
MalfunctionJul 27, 2023Fracture; Fracture
DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED,DIFFERENT DEVICE USED (DIFFERENT MODEL),PROCEDURE COMPLETED PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. EVENT DESCRIPTION: ECN EVENT DESCRIPTION: PHYSICIAN WAS TRYING TO INSERT 5FR X 11CM SHEATH AND HAVING DIFFICULTY DUE TO SEVERELY SCARRED LEFT COMMON FEMORAL ARTERY ACCESS - PATIENT WITH HISTORY OF OPEN BYPASS SURGERY. HE INSERTED THE J WIRE AND FOLLOWED WITH AN 035 RUBICON AND WHEN TRYING TO REMOVE THE J WIRE THE RT SCRUB ASSISTANT NOTICED THE INNER CORE WAS REMOVED BUT THE OUTER PORTION OF THE WIRE REMAINED IN THE RUBICON. THE PHYSICIAN USED AN 11 BLADE TO CUT A PORTION OF THE RUBICON CATHETER TO SUCCESSFULLY REMOVE THE REMAINING OUTER CORE OF THE WIRE. A ZIPWIRE WAS THEN INSERTED INTO THE RUBICON AND THE RUBICON WAS REMOVED. BOTH ITEMS WERE REMOVED FROM THE STERILE FIELD AND THE CASE PROCEEDED. AFTER MULTIPLE DILATIONS, THE PHYSICIAN WAS ABLE TO USE AN AMPLATZ WIRE TO SUCCESSFULLY INSERT THE 5FR SHEATH AND CONTINUE WITH THE PROCEDURE WITHOUT ANY FURTHER ISSUES. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: STATED ABOVE WHAT IS THE NEXT COURSE OF ACTION?: N/A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17405445 ↗
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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