Cardiva VASCADE 6/7F VCS 700-580IRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M729700580I0), received between Dec 23, 2015 and Feb 23, 2016 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2016Material Separation

  THE DEVICE WAS INSERTED INTO THE SHEATH, THE DISC WAS DEPLOYED, TEMPORARY HEMOSTASIS WAS ACHIEVED AND THE SHEATH WAS REMOVED. THE DOCTOR INSERTED THE KEY INTO THE LOCK AND RETRACTED THE BLACK SLEEVE WITHOUT ISSUE. THE COLLAGEN WAS DEPLOYED, THE DISC WAS DE-DEPLOYED AND THE DEVICE WAS REMOVED. FINAL HEMOSTASIS WAS ACHIEVED WITH THE DEVICE. AFTER DEVICE WAS REMOVED FROM PATIENT AND PRESSURE WAS BEING HELD THE CARDIVA LREPRESENTATIVE NOTICED A SEPARATION OF THE DISTAL OUTER SLEEVE FROM THE JOINER. THE DISTAL OUTER SLEEVE WAS STILL ON THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5455729 ↗
• MalfunctionJan 27, 2016Collapse; Retraction Problem; Material Separation

  THE VASCADE DEVICE WAS PUT INTO SHEATH AND DEPLOYED. TEMPORARY HEMOSTASIS WAS ACHIEVED AND THE SHEATH WAS REMOVED. THE DOCTOR INSERTED THE KEY INTO THE LOCK AND ATTEMPTED TO PULL BACK THE BLACK SLEEVE, BUT THE SLEEVE WOULD NOT RETRACT. AT THIS POINT THE DISC WAS COLLAPSED AND THE DOCTOR REMOVED THE DEVICE. IT WAS THEN OBSERVED THAT THE WHITE MARKER BAND DISTAL OUTER SLEEVE SEPARATED FROM JOINER AND WAS REMOVED WITH THE DEVICE. IT SHOULD BE NOTED THAT THE COMPLETE DEVICE WAS REMOVED. MANUAL COMPRESSION WAS HELD TO ACHIEVE FINAL HEMOSTASIS. NO INJURY OR COMPLICATIONS NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5395068 ↗
• InjuryDec 23, 2015Insufficient Device Problem Information

  THE DOCTOR REPORTED THAT A PATIENT THAT HAD VASCADE IMPLANTED HAD TO HAVE SURGICAL EXTRACTION OF A COLLAGEN PLUG REMOVED WITH CLOT FROM A PATIENT'S SUPERFICIAL FEMORAL ARTERY. UPON MORE INVESTIGATION THE IMPLANT WAS ON (B)(6) 2015 AT (B)(6). THE CARDIVA REPRESENTATIVE INTERVIEWED THE RT'S WHO DO IMPLANTS AND THE RT'S DON'T REMEMBER ANY SPECIFIC PROBLEMS WITH IMPLANTATION. THE PATIENT HAS MULTIPLE SYSTEM COMPLICATIONS: DIABETES MELLITUS, RHEUMATIC HEART DISEASE, AND PERIPHERAL VASCULAR DISEASE. THE PROCEDURE WAS A LEFT FEMORAL PTA/ATHERECTOMY AND L PROFUNDA PTA WITH RIGHT FEMORAL CLOSURE WITH A 6/7FR VASCADE. A CARDIVA REPRESENTATIVE WAS NOT PRESENT ON THE PROCEDURE. I INTERVIEWED THE RT'S WHO IMPLANTED AND THEY RECALLED A ROUTINE IMPLANT ASIDE FROM THE PATIENT BEING SMALL. ALL OF THIS INFORMATION IS RETROSPECTIVE RECOLLECTIONS ON THE SITUATION. PATIENT IS DOING FINE POST PROCEDURE.

  Patient problems: Thrombosis

  MAUDE report 5324576 ↗