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Starter™ Guidewire M001491751Recalls & 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
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 08714729326830), received between Sep 14, 2022 and Sep 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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

  • Fracture2

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.

  • MalfunctionSep 14, 2022Fracture; Fracture

    EVENT DESCRIPTION: ECN EVENT DESCRIPTION: DR. ADVANCED THE BENTSON WIRE DOWN THE DRAIN TUBE (COOK DRAINAGE CATHETER) LIKE THEY ALWAYS DO TO EXCHANGE DRAINS. THE WIRE THEN WAS GETTING STUCK IN THE DRAINAGE CATHETER AND WOULD NOT COME OUT. THE WIRE THEN SEPARATED AND HAD TO BE PULLED OUT IN A LONG 'STRING' LIKE FASHION AS THE WIRE UNRAVELED. THIS HAS NOW HAPPENED ON 2 OCCASIONS WITH THE SAME LOT NUMBER OF THIS BENTSON WIRE WITH 2 DIFFERENT DRAINS. BOTH WITH THE SAME MD. THE SECOND DRAIN WAS A MERIT RESOLVE CATHETER AND THE WIRE DID THE SAME THING. THE ACCOUNT IS QUESTIONING IF SOMETHING HAS CHANGED WITH THE COATING ON THE WIRE? THE ACCOUNT HAS 14 MORE OF THESE SAME LOT NUMBER WIRES THEY WOULD LIKE TO RETURN AND EXCHANGE FOR 3 NEW BOX(S) OF BENTSONS PLEASE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: WIRE WAS STUCK AND WOULD NOT COME OUT. HAD TO PULL HARD AND SEPARATE THE WIRE. WHAT IS THE NEXT COURSE OF ACTION?: OPENED A DIFFERENT WIRE FROM ANOTHER VENDOR OF THE SAME SIZE WIRE AND EXCHANGED THE DRAIN WITHOUT ANY ISSUE. PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. EVENT DATE: (B)(6) 2022. (B

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15416434 ↗
  • MalfunctionSep 14, 2022Fracture; Fracture

    EVENT DESCRIPTION: ECN EVENT DESCRIPTION: DR ADVANCED THE BENTSON WIRE DOWN THE DRAIN TUBE (COOK DRAINAGE CATHETER) LIKE THEY ALWAYS DO TO EXCHANGE DRAINS. THE WIRE THEN WAS GETTING STUCK IN THE DRAINAGE CATHETER AND WOULD NOT COME OUT. THE WIRE THEN SEPARATED AND HAD TO BE PULLED OUT IN A LONG 'STRING' LIKE FASHION AS THE WIRE UNRAVELED. THIS HAS NOW HAPPENED ON 2 OCCASIONS WITH THE SAME LOT NUMBER OF THIS BENTSON WIRE WITH 2 DIFFERENT DRAINS. BOTH WITH THE SAME MD. THE SECOND DRAIN WAS A MERIT RESOLVE CATHETER AND THE WIRE DID THE SAME THING. THE ACCOUNT IS QUESTIONING IF SOMETHING HAS CHANGED WITH THE COATING ON THE WIRE? THE ACCOUNT HAS 14 MORE OF THESE SAME LOT NUMBER WIRES THEY WOULD LIKE TO RETURN AND EXCHANGE FOR 3 NEW BOX(S) OF BENTSONS PLEASE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: WIRE WAS STUCK AND WOULD NOT COME OUT. HAD TO PULL HARD AND SEPARATE THE WIRE. WHAT IS THE NEXT COURSE OF ACTION?: OPENED A DIFFERENT WIRE FROM ANOTHER VENDOR OF THE SAME SIZE WIRE AND EXCHANGED THE DRAIN WITHOUT ANY ISSUE. PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS EVENT DATE: 2022-8-19.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15416295 ↗

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Sources and updates

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