Starter™ Guidewire M001491571Recalls & reported problems
Lake Region Medical Limited · Straight Fixed Core Guidewire · 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 08714729326748), received between Sep 12, 2025 and Jul 27, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Entrapment of Device1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50014658 ↗MalfunctionSep 12, 2025Entrapment of Device; Entrapment of Device
ECN EVENT DESCRIPTION: LSPV TREATED WITH NO ISSUES. PHYSICIAN DEPLOYED IN FLOWER, RETRACTED THE WIRE FROM LSPV AND ATTEMPTED TO WIRE LIPV. PHYSICIAN STATED THEY FELT A LOT OF RESISTANCE ON THE WIRE AND WAS HARD TO ADVANCE OR PULL BACK INTO THE CATHETER. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? FARAWAVE 31MM REMOVED AND USED NEW BSC STARTER ROSEN WIRE, UNABLE TO ADVANCE FULLY THROUGH THE CATHETER. WHAT IS THE NEXT COURSE OF ACTION? NEW CATHETER PULLED, NO FURTHER ISSUES. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PROCEDURE NUMBER: (B)(6). DEVICE 1: UPN M004PF41M401, MODEL NUMBER NULL, LOT OR SERIAL NUMBER (B)(6). WAS ISSUE PRESENT UPON OPENING PACKAGE? NO. QUESTION: WHAT BRAND/MAKE OF GUIDEWIRE WAS USED? IF A BSC OR MERIT GUIDEWIRE: PLEASE PROVIDE THE UPN & LOT#. ANSWER: BSC STARTER ROSEN 1.5MM J - LOT UNKNOWN. QUESTION: WAS ANY TISSUE SEEN AT THE TIP OF THE CATHETER OR GUIDEWIRE? ANSWER: NO. QUESTION: WERE YOU ABLE TO REMOVE THE GUIDEWIRE AS NORMAL? IF NO: WHAT STATE WAS THE GW IN WHEN THE CATHETER WAS REMOVED? (EX: WITHIN THE GUIDEWIRE, ADVANCED PAST THE TIP, ETC). ANSWER: WAS ABLE T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23035494 ↗
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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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