Enclose II® EN235vRecalls & reported problems
Vitalitec International, Inc. · Anastomosis assist device · Class 2
- 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 00852621004185), received between May 6, 2026 and May 6, 2026 — 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. How this data works · Data updated Oct 13, 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.
MalfunctionMay 6, 2026Material Puncture/Hole
IT WAS REPORTED THAT A DEVICE MALFUNCTION OCCURRED DURING THE USE OF ENCLOSE II. NO HARM TO THE PATIENT OR OTHER ADVERSE HEALTH EFFECTS WERE REPORTED. AFTER INSERTION OF ENCLOSE II INTO THE AORTA, BOTH THE UPPER JAW AND LOWER JAW WERE DEPLOYED; HOWEVER, ADEQUATE HEMOSTASIS COULD NOT BE ACHIEVED. UPON REMOVAL OF ENCLOSE FROM THE AORTA, IT WAS CONFIRMED THAT THERE WAS A HOLE IN THE MEMBRANE. USE OF ENCLOSE WAS DISCONTINUED, AND THE PROCEDURE WAS CONTINUED WITH A PARTIAL CLAMP. NO PATIENT INJURY OR OTHER ADVERSE HEALTH EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25093051 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.