Forté™ H74934949020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729286677), received between Jul 26, 2021 and Aug 5, 2021 — classified as 2 malfunctions.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  NOTE: THIS REPORT IS BEING FILED BASED ON THE RESULTS OF THE DEVICE EVALUATION AND PERTAINS TO THE SECOND OF TWO DEVICES IN THE REPORTED EVENT. MDR 2126666-2021-00030 CAPTURED THE FIRST DEVICE USED IN THIS CASE. DESCRIPTION OF THE EVENT: AFTER THE FIRST FORTE FLOPPY WAS DEFECTIVE (COMPLAINT ALREADY SUBMITTED) AND REMOVED A GUIDEZILLA WAS ADVANCED TO GET BETTER GUIDE SUPPORT. THIS FORTE FLOPPY WIRE WAS OPENED AND ATTEMPTED TO BE ADVANCE THROUGH THE PROXIMAL OPENING OF THE GUIDEZILLA. AFTER SEVERAL ATTEMPTS THE WIRE WAS REMOVED TO FIND IT HAD UNRAVELED AT THE TIP. A 300CM PILOT 50 WAS OPENED AND USED TO CO PLATE THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283217 ↗
• MalfunctionJul 26, 2021Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  DESCRIPTION OF THE EVENT: WIRE WAS DIRECTED DOWN THE PDA. A 2.0X12MM BALLOON WAS ADVANCED. THE BALLOON WOULD GET THE DISTAL END OF THE WIRE AND NOT MOVE ANY FURTHER. AFTER SEVERAL ATTEMPTS OF TRYING THE GET THE BALLOON DOWN THE BALLOON BECAME STUCK ON THE DISTAL END OF THE WIRE. THE WIRE AND BALLOON WERE REMOVED IN ONE PIECE. THE BALLOON WAS FORCIBLY REMOVED FROM THE WIRE. A 300CM PILOT 50 WAS USED TO REWIRE THE LESION. THE BALLOON WAS REINSERTED AND INFLATED AS IT SHOULD HAVE ORIGINALLY. NO PATIENT COMPLICATIONS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION REPORTED THAT THE WIRE WAS DAMAGED AND THE BALLOON WOULD NOT GO FURTHER AND BECAME STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225093 ↗

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 · Terminated
  Boston 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 · Terminated
  Boston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in intravascular interventional procedures.