ENVOY 778-252-90Recalls & reported problems
Cerenovus, Inc. · ENVOY Guiding Catheter SIM 2 90 cm 7F (2.3 mm) .078 Inch (2.0 mm) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704075035), received between Feb 19, 2026 and Feb 19, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Material Separation1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2026Difficult to Remove; Material Separation
IT WAS REPORTED, VIA EMAIL, THAT AN ENVOY, 7F, 90 CM, SIMMONS 2 (77825290/ 31708615) WAS USED FOR A MECHANICAL THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED ENVOY CATHETER- WITHDRAWAL DIFFICULTY FROM VESSEL AND SEPARATION WHILE IN PATIENT. THE PHYSICIAN USED A ZOOM55 REPERFUSION CATHETER (IMPERATIVE CARE, INC.) INSIDE THE ENVOY AND HAD AN 8FR SHEATH (UNSPECIFIED BRAND) FOR FEMORAL ACCESS. DUE TO SEVERE VESSEL TORTUOSITY, THE USER WAS ¿UNABLE TO SELECT TO ADVANCE.¿ THE PHYSICIAN DECIDED TO WITHDRAW THE ENVOY CATHETER BUT EXPERIENCED DIFFICULTY/RESISTANCE. ¿CATHETER DISTALLY BROKE OFF AND REMAINED INSIDE PATIENT.¿ THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿AFTER TRYING TO SELECT IN A TYPE III ARCH WITH VERY TORTUOSITY VESSELS, UNABLE TO SELECT TO ADVANCE. WHEN, PHYSICIAN DECIDED TO PULL THE 7FR ENVOY CATHETER SIM 2 BY 90CM LENGTH, IT WAS HARD TO PULL CATHETER. CATHETER DISTALLY BROKE OFF AND REMAINED INSIDE PATIENT. PHYSICIAN HAD USED A ZOOM 55 INSIDE THE ENVOY AND HAD AN 8FR SHEATH FOR FEMORAL ACCESS.¿ ON 14-FEB-2026, ADDITIONAL EVENT INFORMATION WAS RECEIVED FROM THE SALES REPRESENTATIVE. SUMMARY: PER THE INFORMATION PROVIDED, IT WAS CONFIRMED THAT THE CATHETER ST
Patient problems: Insufficient Information
MAUDE report 24388305 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.