Enclose II® EN240vRecalls & reported problems
Vitalitec International, Inc. · Anastomosis assist device · Class 2
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 00852621004192), received between May 6, 2026 and May 6, 2026 — classified as 1 malfunction.
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. 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
- Difficult to Remove1
- Mechanical Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Mechanical Problem; Difficult to Remove
IT WAS REPORTED THAT AFTER ENCLOSE2 WAS INSERTED INTO THE AORTA AND A PUNCH-OUT WAS PERFORMED, BRISK BLEEDING OCCURRED, PROMPTING DISCONTINUATION OF ITS USE. WHEN ATTEMPTS WERE MADE TO WITHDRAW THE DEVICE BY TURNING THE UPPER JAW AND LOWER JAW DIALS, IT COULD NOT BE REMOVED. AFTER SEVERAL ADDITIONAL ATTEMPTS, IT WAS FINALLY ABLE TO BE WITHDRAWN. AFTER INSERTION OF THE SUBJECT DEVICE AND COMPLETION OF THE PUNCH-OUT, BLEEDING BECAME UNCONTROLLABLE. A DECISION WAS MADE TO TEMPORARILY WITHDRAW THE DEVICE; HOWEVER, THE LOWER JAW DIAL DID NOT ROTATE SMOOTHLY, AND IT TOOK TIME TO FULLY CLOSE THE LOWER JAW, RESULTING IN DIFFICULTY WITHDRAWING THE DEVICE. THE DEVICE WAS ULTIMATELY WITHDRAWN WITHOUT INCIDENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER ENCLOSE II DEVICE. HEMOSTASIS WAS CHECKED USING THE EXTENSION TUBE, AND NO PROBLEMS WERE OBSERVED. ALTHOUGH THERE WAS DIFFICULTY IN REMOVING THE PRODUCT, THERE WAS NO DAMAGE TO THE AORTA. THE PHYSICIAN STATED THAT THERE WERE NO PROBLEMS DURING THE SCALPEL INCISION OR WHEN USING THE PUNCHER. NO PARTICULAR INFORMATION HAS BEEN OBTAINED REGARDING THE PATIENT'S OUTCOME. THE PHYSICIAN HAS USED THIS PRODUCT IN APPROXIMATELY 10 CASES.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25095035 ↗
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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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