ENVOY 778-258-90Recalls & reported problems
Cerenovus, Inc. · ENVOY Guiding Catheter MPD 90 cm 7F (2.3 mm) .078 Inch (2.0 mm) · Class 2
All models of ENVOY (15)
Data updated Oct 16, 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 10886704075004), received between Jan 24, 2025 and Jan 24, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
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.
MalfunctionJan 24, 2025Crack; Crack
AS REPORTED BY THE FIELD, WHEN UNPACKING THE ENVOY CATHETER (77825890, 31253144) THE HEALTH CARE PROFESSIONAL (HCP), NOTICED THAT IT WAS TORN AT THE TOP OF THE HUB AND THEN PLACED IT ON ITS SIDE. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JAN-2025 INDICATED THAT THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21230911 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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