Guider Softip™ XF H965100480Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729202523), received between Dec 10, 2019 and Dec 15, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

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-0014-2024 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT PATIENT WITH STROKE WAS TREATED SUCCESSFULLY. HOWEVER, THE NEXT DAY PATIENT HAD SECOND STROKE AND HAD TO BE RETREATED. PHYSICIAN PERFORMED THROMBECTOMY PROCEDURE TO REMOVE THE CLOT. DURING THE PROCEDURE THE OPERATOR FOUND THE RADIOPAQUE MARKER OF THE SUBJECT GUIDE CATHETER IN THE M1 SEGMENT FROM THE FIRST PROCEDURE. ATTEMPTS WERE MADE TO REMOVE THE MARKER BUT WERE UNSUCCESSFUL AND WAS LEFT INSIDE THE PATIENT¿S ANATOMY. THERE WAS SURGICAL DELAY REPORTED DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient; Muscle Weakness/Atrophy; Paralysis; Stroke/CVA; Syncope/Fainting; Thrombosis/Thrombus

  MAUDE report 18334427 ↗
• MalfunctionMay 23, 2022Peeled/Delaminated; Peeled/Delaminated

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE CATHETER (SUBJECT DEVICE) PTFE COATING WAS PEELING. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14468940 ↗
• InjuryDec 10, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE GUIDE CATHETER (SUBJECT DEVICE) DISTAL RADIOPAQUE MARKER CAME OFF DURING EMBOLIZATION OF A DURAL FISTULA. THE OPERATOR CHANGED THE INITIAL SHEATH TO A 12F SHEATH AND EXCHANGED THE GUIDEWIRE. THEN THE OPERATOR INFLATED A 8 X 4 BALLOON INSIDE THE TIP RING THAT BROKE OFF AND MANAGED TO RETRIEVE THE TIP FROM THE PATIENT. THIS WAS POSSIBLE AS THE WIRE KEPT THE RADIOPAQUE TIP CONSTRAINED INSIDE THE PATIENT. THERE WAS 1 HOUR SURGICAL DELAY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9448359 ↗