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Guider Softip™ XF M003101480Recalls & reported problems

Boston Scientific Corporation · Guide Catheter · Class 2

All models of Guider Softip XF (17)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729244356), received between Dec 27, 2018 and Dec 27, 2018 — classified as 1 injury.

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

1 FDA recall record name this device's identifier, 1 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-0022-2024 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Device problems

  • Material Separation1

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.

  • InjuryDec 27, 2018Material Separation; Material Separation

    IT WAS REPORTED THAT DURING THE STENTING PROCEDURE AT LEFT VERTEBRAL ARTERY FOR COMPLEX CALCIFIED 70% STENOSIS, THE TIP OF THE SUBJECT CATHETER WAS DETACHED AND STUCK IN THE PROXIMAL PART OF THE STENT. WHEN THE PHYSICIAN ADVANCED ANOTHER CATHETER TO THE SUBCLAVIAN ARTERY AND ADVANCED A WIRE THROUGH THE STENT, IT WAS NOTICED THAT THE DETACHED TIP WAS MOVING CLOSER TO THE PROXIMAL END TO THE SUBCLAVIAN PART OF THE STENT. THEREFORE, THE PHYSICIAN DEPLOYED ANOTHER STENT IN THE VERTEBRA ARTERY TO LOCK THE DETACHED TIP BETWEEN THE TWO STENTS. AFTER THE PROCEDURE, THE PATIENT WAS WITH 30% RESIDUAL STENOSIS BUT FREE FLOW AND NO SIGNS OF THE DISTAL EMBOLI. THE PATIENT WAS ADMINISTRATED WITH ACETYLSALICYLIC ACID (ASA) FOR LIFETIME, AND CLOPIDOGREL FOR AT LEAST THREE MONTHS. NO FURTHER INFORMATION IS AVAILABLE FOR NOW.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 8200093 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

Sources and updates

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