ENVOY 671-256-05DBRecalls & reported problems
Medos International Sàrl · ENVOY DA XB Guiding Catheter MPC 105cm 6F (2.0mm) 0.071 Inches (1.8mm) · Class 2
All models of ENVOY (5)
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 10886704075080), received between Jul 14, 2025 and Jul 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- 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.
MalfunctionJul 14, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENVOY DA XB, 6F, 105CM, MPC GUIDE CATHETER (67125605DB, 31242284) WAS DELIVERED TO THE PATIENT. THE PROXIMAL END OF THIS GUIDE CATHETER WAS OBSERVED TO BE KINKED/BENT. THE DOCTOR REMOVED THE GUIDE CATHETER FROM THE PATIENT AND SWITCHED TO ANOTHER GUIDE CATHETER WITH THE SAME UNSPECIFIED MICROCATHETER. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-JUL-2025 INDICATED THAT THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM (606S255X, LOT UNKNOWN). THE DEVICE DEFICIENCY DID NOT RESULT IN PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494094 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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