Guider Softip™ XF M003101620Recalls & reported problems
Boston Scientific Corporation · Guide Catheter · Class 2
All models of Guider Softip XF (17)
Data updated Oct 16, 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 08714729283539), received between Oct 6, 2017 and Apr 8, 2019 — 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 16, 2026.
Recalls naming this device
- Jul 27, 2023Open, 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-0023-2024 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2019Break; Break
IT WAS REPORTED THAT A CRACK WAS FOUND IN THE GUIDE CATHETER . THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8493944 ↗MalfunctionOct 6, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING THE PROCEDURE, A LEAK WAS FOUND BETWEEN THE HUB AND THE CATHETER. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6919461 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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