enableCV IntraClude™ Intra-Aortic Occlusion Device ICF100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840479401010), 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).

4 other recalls cover devices cleared under the same FDA submission (K132175, K163693); they may or may not involve this specific model.

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.

Most reported problems

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 ANOMALLIES 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 DISSE

  Patient problems: Aortic dissection

  MAUDE report 25486828 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132175, K163693. One submission often covers many models, so check the product and lot details in each record.

• Z-1705-2019 · May 14, 2019 · Terminated
  IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use
• Z-1100-2019 · Jan 16, 2019 · Open, Classified
  Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip des
• Z-1929-2018 · Mar 30, 2018 · Terminated
  Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
• Z-1758-2015 · May 5, 2015 · Terminated
  Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a seale