Guider Softip™ XF M003101420Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729244295), received between Jul 11, 2017 and Nov 8, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- 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-0017-2024 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2020Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) INNER LINING OF THE CATHETER (SUBJECT DEVICE) WAS PEELING SPONTANEOUSLY SHOWING THE INNER METAL LAYER WHEN THE SUBJECT CATHETER WAS REMOVED FROM ITS PACKAGING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10806436 ↗MalfunctionJul 11, 2017Break; Break
IT WAS REPORTED THAT THE GUIDE CATHETER (SUBJECT DEVICE) WAS CRACKED /BROKEN. THERE WERE NO PATIENT CLINICAL CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6704409 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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