Starter™ Guidewire M001491851Recalls & reported problems
Lake Region Medical Limited · Straight Fixed Core Guidewire · Class 2
All models of Starter Guidewire (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729326908), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED PRODUCT MODEL#: 42415, RELATED PRODUCT SERIAL#: NO VALUE FOUND, RELATED PRODUCT UPN#: M001491851, RELATED PRODUCT BATCH/LOT: 0009622743, RELATED PRODUCT FAMILY: STARTER, MATERIAL NUMBER: M001491851, STERILE LOT NUMBER: NO VALUE FOUND, SOLD TO ACCOUNT NUMBER: NO VALUE FOUND, RETURNED PRODUCT EXPECTED: NO, BSC PRODUCT RETURN DATE: NO VALUE FOUND, LOCATION DESCRIPTION: NO VALUE FOUND. DEVICE/PROCEDURE OUTCOME: PROCEDURE CANCELLED/RESCHEDULED, NON BSC PRODUCT USED PATIENT OUTCOME: F23: UNEXPECTED MEDICAL INTERVENTION, F2303: MEDICATION REQUIRED, F08: HOSPITALIZATION OR PROLONGED HOSPITALIZATION, F1001: ABSENCE OF TREATMENT, 104: CANCELLED/RESCHEDULED - POST SEDATION/SEDATION UNKNOWN EVENT DESCRIPTION: ECN EVENT DESCRIPTION: PHYSICIAN USED AN AGILIS STEERABLE SHEATH INSTEAD OF THE FARADRIVE. PHYSICIAN NOTED THE AGILIS WAS DIFFICULT TO STEER. MAPPING SPECIALIST FROM ABBOTT NOTED SHE WAS NOT ABLE TO VISUALIZE THE WIRE. ALL CONNECTIONS WERE CHECKED. PHYSICIAN NOTED DROP IN BP. PERICARDIAL EFFUSION NOTED AND DRAINED. PROCEDURE WAS NOT COMPLETED. TOTAL OF 26 ABLATIONS. (LEFT SUPERIOR 4 BASKET, 4 FLOWER, LEFT INFERIOR 8 FLOWER, RIGHT SUPERIOR 6 BASKET, 6 FLOWER, RIGHT INFERIOR NO ABLA
Patient problems: Pericardial Effusion
MAUDE report 23552837 ↗
Other Wire, Guide, Catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page