Bandit™ guidewire 7444Recalls & reported problems
Vascular Solutions, Inc. · Class 2
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 M20674440), received between Oct 25, 2018 and Mar 11, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
- Peeled/Delaminated1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2020Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn
IT WAS REPORTED THAT A CTO OF THE RCA WITH TORTUOSITY AND HEAVY CALCIUM BURDEN WAS PERFORMED. THE BANDIT GUIDEWIRE NAVIGATED THE MICROCHANNEL WELL, HOWEVER, THE TURNPIKE SPIRAL WAS UNABLE TO GET THROUGH THE TIGHT CALCIFIED BEND AND CONTINUOUSLY BUCKLED AND THEY WERE UNABLE TO ADVANCE A BALLOON OVER THE BANDIT WIRE AS IT WAS GETTING STUCK ON THE WIRE. UPON REMOVAL OF THE WIRE IT WAS SEEN THAT THE POLYMER HAD BUNCHED UP. THEY THEN TOOK A DIFFERENT (SECOND) WIRE AND WERE UNABLE TO ADVANCE THIS WIRE THROUGH THE TIGHT LESION. FOR THEIR FINAL ATTEMPT THEY USED ANOTHER WIRE FOR A "HOLE-IN-ONE" TECHNIQUE WHERE THEY SPIN THE WIRE AS FAST AS THEY CAN AND HOPE THAT IT WILL GO THROUGH THE MICROCHANNEL. THEY HAD ISSUES ADVANCING THIS WIRE THROUGH THE SAME TIGHT CALCIFIED BEND AND THE TURNPIKE SPIRAL WAS STILL UNABLE TO MOVE BEYOND THIS BEND. DURING THE SPINNING OF THIS WIRE, IT SNAPPED. DUE TO THE CTO OF THE RCA AND THE HEAVY CALCIUM. SITE DECIDED TO LEAVE THIS PIECE OF WIRE IN THE VESSEL AND ABORTED THE CASE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9819764 ↗MalfunctionOct 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
WHILE PHYSICIAN WAS USING THE BANDIT GUIDEWIRE, IT KNUCKLED IN A STENT. THE WIRE BECAME KNOTTED WHEN HE KNUCKLED IT, AND THE COILS UNCOILED/SEPARATED FROM THE CORE WIRE. THE DEVICE REMAINED INTACT AND NO PIECES OF THE WIRE WERE LEFT IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8006248 ↗
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.
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