Starter™ Guidewire M001491471Recalls & reported problems
Lake Region Medical Limited · Bentson 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 08714729326663), received between Jun 13, 2022 and Jun 13, 2022 — 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.
MalfunctionJun 13, 2022Fracture; Fracture
EVENT DESCRIPTION: PLEASE PROVIDE A BRIEF SUMMARY OF THE EVENT THAT INCLUDES ANY ADDITIONAL DETAILS THAT YOU HAVE NOT ALREADY PROVIDED: NA. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: BALLOON AND WIRE REMOVED AS ONE. WHAT IS THE NEXT COURSE OF ACTION?: FINISHED PROCEDURE WITH NO ISSUE. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: NO. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: NO. PATIENT OUTCOME: FULLY RECOVERED. DEVICE ACQUIRED FROM A DISTRIBUTOR?: NO. EVENT DATE: (B)(6) 2022. (B)(4). DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED,UNABLE TO USE DEVICE - ATTEMPTED,DIFFERENT DEVICE USED (DIFFERENT MODEL). PATIENT OUTCOME: NO HEALTH CONSEQUENCES OR IMPACT. PROCEDURE DATE: (B)(6) 2022. TYPE OF PROCEDURE: TYPE OR PROCEDURE: PTA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14682030 ↗
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- 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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