Starter™ Guidewire M001491201Recalls & reported problems
Lake Region Medical Limited · "J" Curved 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
- 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 08714729326533), received between Nov 10, 2023 and Nov 10, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Peeled/Delaminated1
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.
MalfunctionNov 10, 2023Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED VIA ALTERNATIVE METHOD,DIFFERENT DEVICE USED (SAME MODEL) PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT EVENT DESCRIPTION: IT WAS REPORTED THAT: THE GUIDEWIRE LOST THE COATING OF "J" TIP DURING USE. IN ORDER TO COMPLETE THE PROCEDURE, WE REPLACED THE MD WITH THE SAME REFERENCE, BUT BATCH NUMBER IS UNKNOWN. ADDL INFO: THE CONCERNED DEVICE(S) IS(ARE) KEPT IN THE STATE: DESTERILIZED USED/HAS BEEN IN CONTACT WITH BLOOD OR OTHER SUBSTANCES PRESENTING A BIOLOGICAL RISK. NOT SATISFACTORILY DECONTAMINATED TO BE PICKED UP FROM THE PHARMACY BY YOUR CARRIER OR SALES REPRESENTATIVE. AS THE DEVICE IS CONTAMINATED, PLEASE CONTACT THE NON-CONFORMITY DEPARTMENT BEFOREHAND TO DETERMINE THE RETURN ARRANGEMENTS. PRECAUTIONARY MEASURE: NO BATCH WITHDRAWAL SO FAR COMMENTS: I KINDLY ASK YOU TO SEND ME YOUR ANALYSIS OF THIS FILE AND NOTIFY ME IF YOU HAVE RECEIVED OTHER COMPLAINTS ABOUT THIS DEVICE AND BATCH IN PARTICULAR. I WOULD LIKE TO INFORM YOU THAT YOUR EXPERT REPORT ESTABLISHED ON THE MEDICAL DEVICE IS TRANSMITTED TO THE UHC (UNIVERSITY HOSPITAL CENTER) AND MAY BE COMMUNICATED TO PATIENTS WHO REQUEST IT, IN ACCORDANCE WITH THE OPINION OF THE CO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18109797 ↗
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- 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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