ENVOY 670-260-00BRecalls & reported problems
Cerenovus, Inc. · ENVOY XB Guiding Catheter STR 100 cm 6F (2.0 mm) .070 Inch (1.8 mm) · Class 2
All models of ENVOY (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704031789), received between Dec 26, 2024 and Dec 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2024Material Puncture/Hole; Material Puncture/Hole
THE HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS A ¿HOLE IN THE CATHETER.¿ THE CATHETER REPORTED WAS AN ENVOY® XB GUIDING CATHETER (67026000B / 31189199). THE ISSUE WAS OBSERVED PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. ON 12-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ISSUE OCCURRED ON (B)(6) 2024 PRE-OP TO A CEREBRAL DIAGNOSTIC PROCEDURE. THE ENVOY WAS REPLACED WITH ANOTHER ENVOY GUIDING CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO NEGATIVE PATIENT IMPACT AND NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21019793 ↗
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- 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
- 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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