enableCV EndoReturn™ Arterial Cannula ER21BRecalls & reported problems
Enablecv Inc. · EndoReturn™ Arterial Cannula - ER21B · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840479401218), received between Jun 12, 2026 and Jun 12, 2026 — classified as 1 death.
The most frequently reported specific device problem is “Use of Device Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Aortic dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJun 12, 2026Use of Device Problem
A EVENT LEADING TO DEATH WAS REPORTED TO BE POSSIBLY ASSOCIATED WITH THE USE OF THE ER21B CANNULA AND ICF100 CATHETER. THE PHYSICIAN INITIALLY THOUGHT THE PATIENT'S VESSEL WAS TOO SMALL, BUT THEN THE SURGEON CUT THE VESSEL DOWN AND DECIDED TO MOVE FORWARD WITH THE USE OF THE ICF100. IT WAS REPORTED THAT THE GUIDEWIRE POSSIBLY GOT CAUGHT AT SOME POINT IN THE VESSEL (IT IS UNCLEAR IF THAT IS THE WIRE FOR THE ENDORETURN OR THE ICF100). THE ICF100 WAS NOT YET INFLATED. IT ALSO IS PRESUMED THAT SURGICAL TECHNIQUE OR AN ANOMALY WITH THE WIRE COULD HAVE BEEN RELATED TO THE EVENT, THOUGH NO ABNORMALITIES OR ANOMALIES WERE REPORTED. NO RESISTANCE MENTIONED DURING ADVANCEMENT. ISSUE WAS NOT NOTICED UNTIL THE ICF100 WAS IN THE ASCENDING (PRIOR TO INFLATION). PREOP SCAN WAS WHEN THE PATIENT WAS SITTING UP SO THE DOCTOR DIDN'T GET A GOOD FEMORAL VIEW PRIOR TO THE PROCEDURE. ULTRASOUND BEFORE PROCEDURE OF FEMORAL VESSELS WAS APPROXIMATE FOR MEASUREMENT (6.8 MM). WHEN THEY DID THE CUT DOWN, THEY THOUGHT THE VESSEL WAS LARGE ENOUGH. SURGEON CANNULATED WITH ER21B FOLLOWED BY PLACEMENT OF INTRACLUDE. SHORTLY AFTER LEFT AND RIGHT RADIAL PRESSURES WENT TO 0 AND TEE CONFIRMED A RETROGRADE AORTIC DISSEC
Patient problems: Aortic dissection
MAUDE report 25486855 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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