Guider Softip™ XF M003101440Recalls & 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
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729244318), received between Apr 28, 2017 and Apr 28, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air Leak” (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-0019-2024 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Air Leak1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2017Air Leak; Air Leak
DURING TREATMENT OF A P-COM ANUERYSM, THE PHYSICIAN REPORTED THAT THE GUIDE CATHETER HUB WAS LEAKING. THE PHYSICIAN BELIEVES THAT AIR BUBBLES WERE INSERTED INTO THE GUIDE CATHETER DUE TO THE HUB LEAK AND IT MIGHT CAUSE AIR EMBOLISM TO THE PATIENT. NO PATIENT ADVERSE CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION RECIEVED, INDICATED, THAT AS OF TODAY, THE PATIENT HAS NO NEUROLOGICAL DEFICITS AND IS IN GOOD CONDITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6530922 ↗
Other CATHETER, PERCUTANEOUS devices
- WATCHMAN FXD Curve™ Access System M635TU80020Boston Scientific Corporation · Catheter, percutaneous1 recall47 deaths654 reports
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page