Forté™ H74934949070Recalls & reported problems
Lake Region Medical · Class 2
Data updated Oct 16, 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 08714729286721), received between Oct 16, 2023 and Oct 16, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K011968); they may or may not involve this specific model.
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
- Break1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2023Break; Break
EVENT DESCRIPTION: IT WAS TOLD TO ME THAT THE OPERATOR JAIL STENTED THE CORONARY WIRE BEHIND THE STENT AND WHEN REMOVING THE FORTE WIRE FROM BEHIND THE STENT, THE DISTAL PORTION OF THE WIRE WAS STRIPPED OFF OF THE WIRE CORE AND WAS LEFT IN THE PATIENTS ARTERY DISTAL TO THE STENT. PATIENT IS STABLE WITHOUT DEFICITS. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: REMOVAL OF JAILED WIRE WHAT IS THE NEXT COURSE OF ACTION?: LEAVE PORTION OF WIRE IN PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS ADDITIONAL INFORMATION RECEIVED ON 03OCT2023: THE FORTE WIRE WAS THE JAILED CORONARY WIRE. NO PICTURE. THE WIRE WAS LEFT WHERE IT WAS, BEHIND THE STENT . THEY COULD NOT RETRIEVE. YES FLUOROSCOPY WAS USED. YES THERE WAS RESISTANCE. IT WAS BEHIND THE DEPLOYED STENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17939778 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K011968. One submission often covers many models, so check the product and lot details in each record.
- Z-1486-2009 · May 12, 2009 · TerminatedBoston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures.
- Z-1487-2009 · May 12, 2009 · TerminatedBoston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in intravascular interventional procedures.
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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