ENVOY 670-258-90BRecalls & reported problems
Cerenovus, Inc. · ENVOY XB Guiding Catheter MPD 90 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 10886704031765), received between Feb 2, 2026 and Feb 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Material Twisted/Bent1
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.
MalfunctionFeb 2, 2026Crack; Material Twisted/Bent
IT WAS REPORTED, VIA EMAIL, THAT AN ENVOY 6F, XB MPD 90CM (67025890B / 31663293), WAS TO BE USED FOR A CAROTID STENTING PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED A KINK AND A CRACK OF THE ENVOY. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿THE PRODUCT ARRIVED BROKEN IN ITS ORIGINAL PACKAGING. THE PRODUCT WAS INTENDED FOR USE IN A CAROTID STENTING PROCEDURE, BUT DUE TO DAMAGE TO THE PRODUCT, IT WAS NOT USED IN THE PATIENT, CAUSING A DELAY IN THE PROCEDURE. THE DEVICE HAS BENDING/BREAKAGE. THE DAMAGE WAS NOTICED BEFORE THE PRODUCT WAS USED ON THE PATIENT. NOTHING WAS OBSTRUCTING THE CATHETER. THE CATHETER WAS NOT FLUSHED. NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24234375 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
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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
- 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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