Circulo DAIBW-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816349012662), received between Dec 13, 2022 and Dec 3, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Entrapment of Device; Entrapment of Device

  ATTEMPT TO CROSS THE VALVE WITH THE DELIVERY SYSTEM AND WAS UNSUCCESSFUL AS THE SYSTEM WAS HITTING CALCIUM. ATTEMPTED TO REMOVE THE DELIVERY SYSTEM TO CHANGE OUT THE WIRE AND THE CIRCULO XS WIRE WAS STUCK IN THE DELIVERY SYSTEM. THE PHYSICIAN HAD TO PULL THE ENTIRE SYSTEM OUT WITH THE WIRE AND RE-CROSS THE VALVE WITH A STRAIGHT WIRE. 2ND ATTEMPT MADE TO CROSS THE VALVE WITH THE DELIVERY SYSTEM AND UNSUCCESSFUL AGAIN. THE PHYSICIAN ABORTED THE CASE WITH NAVITOR AND HAD EDWARDS COMPLETE THE CASE WITH A SAPIEN IMPLANT, USING THE STEERABLE SHEATH TO CROSS THE VALVE. ADDITIONAL INFORMATION: QUESTION: HAS THE HEALTHCARE PROFESSIONAL STATED THAT THEY BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT? ANSWER: NO. QUESTION: PATIENT STATUS? ANSWER: STABLE AND DISCHARGED QUESTION. WERE ALL STEPS PERFORMED PER IFU? ANSWER: YES QUESTION: WAS PRE-BAV PERFORMED? ANSWER: YES 24 TRUE DILATION QUESTION: WAS THERE ANY DAMAGE NOTED TO THE CIRCULO WIRE PRIOR TO OR AFTER USE? ANSWER: YES - STUCK IN THE DELIVERY SYSTEM AND SENT BACK QUESTION: WAS THERE DAMAGE TO THE FIRST FLEXNAV DELIVERY SYSTEM? ANSWER: NO, OTHER THAN THE WIRE STUCK INSIDE QUESTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706455 ↗
• MalfunctionJul 10, 2025Entrapment of Device; Entrapment of Device

  ADDITIONAL INFORMATION: QUESTION: CAN YOU PLEASE CONFIRM WAS A CATHETER ADVANCED INTO THE TREATMENT AREA OVER THE CIRCULOTM GUIDEWIRE PRIOR TO WITHDRAWING THE WIRE. ANSWER: THE CATHETER WAS ADVANCED OVER THE CIRCULO WIRE INTO THE TREATMENT AREA. THE WIRE WAS MANIPULATED WITHOUT ISSUE IN THE TREATMENT AREA. THE CATHETER WAS REMOVED FROM TREATMENT AREA WITHOUT ISSUE WITH WIRE STILL IN THE HEART. ENTIRE SYSTEM WAS REMOVED TOGETHER FROM BODY WITHOUT ISSUE. ON THE TABLE, AFTER VALVE WAS DEPLOYED, THE WIRE WAS UNABLE TO BE PULLED THROUGH FLEXNAV SYSTEM AND GOT STUCK. WAS NOT ABLE TO BE PUSHED THROUGH THE SYSTEM EITHER AT THIS POINT. QUESTION: CAN YOU PLEASE CONFIRM WAS THE CIRCULOTM GUIDEWIRE PULLED BACK COMPLETELY INTO THE CATHETER? ANSWER: IN THE BODY NO IT WAS NOT. ON THE TABLE IT WAS PULLED BACK INTO THE CATHETER AND THIS IS WHEN IT GOT STUCK. QUESTION: CAN YOU PLEASE CONFIRM WAS THE CIRCULOTM GUIDEWIRE WITHDRAWN FROM THE CATHETER. ANSWER: THE CATHETER WAS REMOVED FROM TREATMENT AREA WITHOUT ISSUE WITH WIRE STILL IN THE HEART. ENTIRE SYSTEM WAS REMOVED TOGETHER FROM BODY WITHOUT ISSUE. ON THE TABLE, AFTER VALVE WAS DEPLOYED, THE WIRE WAS UNABLE TO BE PULLED THROUGH FLEXNAV SYSTEM AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468558 ↗
• MalfunctionAug 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION PROVIDED 30AUG2024: QUESTION: HOW THIS PROCEDURE WAS COMPLETED (I.E., ANOTHER CIRCULO WIRE, A DIFFERENT MODEL GUIDEWIRE, OR WAS THE ORIGINAL CIRCULO WIRE USED TO COMPLETE THE PROCEDURE)? ANSWER: WIRE WAS REMOVED THROUGH SGC DILATOR. SGC WAS ALREADY ACROSS SEPTUM SO WIRE WAS MERELY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062952 ↗
• MalfunctionDec 13, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  USED CIRCULO XS WIRE TO DO PREBAV AND DEPLOY 27MM PORTICO VALVE. UPON ATTEMPT TO REMOVE CIRCULO WIRE FOR A WIRE EXCHANGE, THE WIRE BECAME STUCK IN THE DELIVERY SYSTEM. UPON DIFFICULT REMOVAL, WIRE CAME OUT FRAYED WITH THE TIP STILL ATTACHED. ADDITIONAL INFORMATION RECEIVED NOVEMBER 22, 2022: Q1. WAS THERE ANY DAMAGE NOTED TO THE CIRCULO GUIDEWIRE PRIOR TO USE? A1. NO. Q2. WAS THERE ANY RESISTANCE NOTED DURING THE INITIAL PLACEMENT OF THE CIRCULO GUIDEWIRE WITHIN THE PATIENT OR AT ANY TIME PRIOR TO THE RESISTANCE NOTED WITH THE DELIVERY SYSTEM AND THE GUIDEWIRE? A2. NO. Q3. WHAT WAS THE MODEL OF THE BALLOON CATHETER USED IN THE PROCEDURE TO PERFORM THE BAV? A3. TRUE BALLOON. Q4. WAS BAV SUCCESSFULLY COMPLETED OVER CIRCULO WIRE? A4. YES. Q5. WAS BAV CATHETER REMOVED SUCCESSFULLY OVER CIRCULO WIRE? A5. YES. Q6. IF THE BAV CATHETER WAS REMOVED OVER THE CIRCULO WIRE, WAS THERE ANY RESISTANCE FELT AT ANY POINT? A6. NO. Q7. WHAT WAS THE REASON FOR THE WIRE EXCHANGE? A7. POST VALVE PLACEMENT, DIFFERENT WIRE NEED TO MAINTAIN VESSEL ACCESS FOR VESSEL CLOSURE DEVICES. Q8. THE EVENT DESCRIPTION MENTIONS THE PORTICO VALVE. PLEASE CONFIRM IF THE ABBOTT FLEX NAV DELIVERY SYSTEM WAS USED OR A DIFF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973206 ↗