Starter™ Guidewire M001491341Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729326601), received between Oct 18, 2021 and Oct 18, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
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
- Fracture3
- Appropriate Device Problem Term/Code Not Available2
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2021Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available
PER SALESFORCE COMPLAINT ID: (B)(4), IT WAS REPORTED THAT: PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS DESCRIPTION OF THE EVENT: WIRE APPEARED TO BE DAMAGED UPON TAKING THE WIRE OUT OF THE HOOP. THERE APPEARED TO BE A SEPARATION OF THE WIRE AT THE DISTAL TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12652174 ↗MalfunctionOct 18, 2021Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
PER SALESFORCE COMPLAINT ID: (B)(4), IT WAS REPORTED THAT: PROCEDURE INFORMATION PROCEDURE DATE: (B)(6) 2021 PROCEDURE TYPE: PERIPHERAL RUNOFF WHAT CONDITION WAS THE PATIENT BEING TREATED FOR?: PAD WHAT WAS THE OUTCOME OF THE PROCEDURE?: PROCEDURE COMPLETED SUCCESSFULLY DESCRIPTION OF THE EVENT PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS DESCRIPTION OF THE EVENT: TECH INDICATED UPON OPENING THE PACKAGE WITH THE GUIDE WIRE THAT THEY NOTICED THE WIRE APPEARED TO BE DEFECTIVE. THEY OPENED ANOTHER WIRE BUT IT APPEARED TO BE DAMAGED AS WELL. FINALLY OPENED A WIRE FROM ANOTHER BOX. ADDITIONAL INFORMATION RECEIVED 5 OCT 2021: COULD YOU FURTHER DESCRIBE THE DAMAGED NOTED ON THE WIRE (I.E PEELED COATING, KINK, FLATTENED, ETC)? IT APPEARS THE DISTAL PORTION / PIECE OF WIRE IS COMING APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12652016 ↗MalfunctionOct 18, 2021Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available
PER SALESFORCE COMPLAINT ID: (B)(4), IT WAS REPORTED THAT: PROCEDURE INFORMATION PROCEDURE DATE: (B)(6) 2021. PROCEDURE TYPE: PERIPHERAL RUNOFF WHAT CONDITION WAS THE PATIENT BEING TREATED FOR?: PAD. WHAT WAS THE OUTCOME OF THE PROCEDURE?: PROCEDURE COMPLETED SUCCESSFULLY DESCRIPTION OF THE EVENT PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. DESCRIPTION OF THE EVENT: TECH INDICATED UPON OPENING THE PACKAGE WITH THE GUIDE WIRE THAT THEY NOTICED THE WIRE APPEARED TO BE DEFECTIVE. THEY OPENED ANOTHER WIRE BUT IT APPEARED TO BE DAMAGED AS WELL. FINALLY OPENED A WIRE FROM ANOTHER BOX. ADDITIONAL INFORMATION RECEIVED 5 OCT 2021: 1. COULD YOU FURTHER DESCRIBE THE DAMAGED NOTED ON THE WIRE (I.E PEELED COATING, KINK, FLATTENED, ETC)? IT APPEARS THE DISTAL PORTION / PIECE OF WIRE IS COMING APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12651981 ↗
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 16, 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