Guider Softip™ XF H965100440Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729202486), received between Sep 25, 2017 and Dec 4, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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 18, 2026.

Recalls naming this device

1. Jul 27, 2023Class IIOpen, Classified

   Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

   Z-0011-2024 · Root cause: Employee error · Recall details · FDA record ↗

2. Aug 9, 2022Class IIOpen, Classified

   The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

   Z-1582-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryDec 4, 2020Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE SUBJECT GUIDE CATHETER BROKE AND MOVED TO A DEEP CERVICAL VEIN AND GOT STUCK. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE BROKEN TIP FRAGMENT AND PROCEEDED TO USE THE SUBJECT CATHETER WITHOUT TIP TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO CLINICAL CONSEQUENCES AND THE PATIENT WAS DISCHARGED. IMAGING WAS DONE APPROXIMATELY ONE MONTH POST PROCEDURE AND THE SUBJECT CATHETER TIP FRAGMENT HAD NOT MOVED FROM THE DEEP CERVICAL VEIN LOCATION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10946040 ↗
• MalfunctionSep 25, 2017Break; Break

  ANALYSIS OF THE DEVICE REVEALED THAT THE GUIDE CATHETER SHAFT WAS BROKEN. THERE WERE NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6890443 ↗