VasCure for Carotid Repair CMCV-072-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00859389005089), received between Oct 11, 2017 and Oct 31, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Off-Label Use” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2020Off-Label Use; Off-Label Use

  AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS PROSPECTIVE PILOT CASE STUDY REPORT PUBLISHED IN THE JOURNAL OF VASCULAR ACCESS 1-7. 2019 TITLED "USING CORMATRIX FOR PARTIAL AND COMPLETE (RE)CONSTRUCTION OF ARTERIOVENOUS FISTULAS IN HAEMODIALYSIS PATIENTS WHO UNDERWENT SURGERY BETWEEN MAY 2016 AND JULY 2018 FOR VASCULAR ACCESS RECONSTRUCTION DUE TO THROMBOSIS OF UNSALVAGEABLE ARTERIOVENOUS FISTULAS, PATIENTS WITH HIGH-FLOW ARTERIOVENOUS FISTULAS AND PATIENTS WITH MICROVASCULATURE IN WHICH AUTOLOGOUS ARTERIOVENOUS FISTULAS DID NOT MATURE. THIS REPORT IS FOCUSED ON PATIENT #3 MDR #2 FOR SECOND PRODUCT USED IN PROCEDURE (PER PUBLICATION TABLE 1: PATIENT DEMOGRAPHICS) FOR A (B)(6) YR. OLD FEMALE WITH BRACHIOCEPHALIC ARTERIOVENOUS FISTULA (AVF) ON RIGHT UPPER ARM. THE SURGEON UTILIZED A TUNNELING DEVICE AND A ONE (1) PIECE OF 2CM X 10CM CORMATRIX ECM FOR CAROTID REPAIR (NOW AZIYO BIOLOGICS MODEL #: CMCV-072-606; LOT #: UNKNOWN) AND ONE (1) PIECE OF 4CM X 7CM (CUT IN TWO HALVES) OF CORMATRIX ECM FOR CARDIAC TISSUE REPAIR (MODEL #: CMCV-120-404, LOT #: UNKNOWN) OFF LABEL TO CREATE AN 24CM (6MM DIAMETER) TUBULAR GRAFT BETWEEN THE CEPHALIC VEIN AND DISTAL RADIAL ARTERY. AT 7 MONTHS PO

  Patient problems: Restenosis; Stenosis; Thrombosis/Thrombus

  MAUDE report 10767482 ↗
• InjuryOct 27, 2020Off-Label Use; Off-Label Use

  AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS PROSPECTIVE PILOT CASE STUDY REPORT PUBLISHED IN THE JOURNAL OF VASCULAR ACCESS 1-7. 2019 TITLED "USING CORMATRIX FOR PARTIAL AND COMPLETE (RE)CONSTRUCTION OF ARTERIOVENOUS FISTULAS IN HAEMODIALYSIS PATIENTS: (RE)CONSTRUCTION OF ARTERIOVENOUS FISTULAS WITH CORMATRIX" WAS REVIEWED. THIS ARTICLE PROVIDES THE RESULTS OF SIX (6) PATIENTS WHO UNDERWENT SURGERY BETWEEN MAY 2016 AND JULY 2018 FOR VASCULAR ACCESS RECONSTRUCTION DUE TO THROMBOSIS OF UNSALVAGEABLE ARTERIOVENOUS FISTULAS, PATIENTS WITH HIGH-FLOW ARTERIOVENOUS FISTULAS AND PATIENTS WITH MICROVASCULATURE IN WHICH AUTOLOGOUS ARTERIOVENOUS FISTULAS DID NOT MATURE. THIS REPORT IS FOCUSED ON PATIENT #2 (PER PUBLICATION TABLE 1: PATIENT DEMOGRAPHICS) WHERE A (B)(6) YR. OLD MALE WITH THROMBOSED RADIOCEPHALIC ARTERIOVENOUS FISTULA (AVF) WITH PTFE GRAFT ON LEFT UPPER ARM. THE SURGEON UTILIZED A TUNNELING DEVICE AND A THREE (3) PIECES OF 2CM X 10CM CORMATRIX ECM FOR CAROTID REPAIR (NOW AZIYO BIOLOGICS MODEL #: CMCV-072-606; LOT #: UNKNOWN) OFF-LABEL TO CREATE AN 30CM (6MM DIAMETER) LOOP BETWEEN BRACHIAL ARTERY AND BASILICVEIN WITH ADDITIONAL OUTFLOW TO CEPHALIC VEIN FOLLOWING EXCISIO

  Patient problems: Restenosis; Stenosis; Thrombosis/Thrombus

  MAUDE report 10744177 ↗
• InjuryOct 27, 2020Off-Label Use; Off-Label Use

  AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS PROSPECTIVE PILOT CASE STUDY REPORT PUBLISHED IN THE JOURNAL OF VASCULAR ACCESS 1-7. 2019 TITLED "USING CORMATRIX FOR PARTIAL AND COMPLETE (RE)CONSTRUCTION OF ARTERIOVENOUS FISTULAS IN HAEMODIALYSIS PATIENTS: (RE)CONSTRUCTION OF ARTERIOVENOUS FISTULAS WITH CORMATRIX" WAS REVIEWED. THIS ARTICLE PROVIDES THE RESULTS OF SIX (6) PATIENTS WHO UNDERWENT SURGERY BETWEEN MAY 2016 AND JULY 2018 FOR VASCULAR ACCESS RECONSTRUCTION DUE TO THROMBOSIS OF UNSALVAGEABLE ARTERIOVENOUS FISTULAS, PATIENTS WITH HIGH-FLOW ARTERIOVENOUS FISTULAS AND PATIENTS WITH MICROVASCULATURE IN WHICH AUTOLOGOUS ARTERIOVENOUS FISTULAS DID NOT MATURE. THIS REPORT IS FOCUSED ON PATIENT #1 (PER PUBLICATION TABLE 1: PATIENT DEMOGRAPHICS) WHERE A 30 YR. OLD MALE WITH ANEURISMATIC RADIOCEPHALIC ARTERIOVENOUS FISTULA (AVF) IN THE RIGHT FOREARM WITH THROMBOSED OUTFLOW FROM ANEURYSMS. THE SURGEON UTILIZED A 2CM X 10CM CORMATRIX ECM FOR CAROTID REPAIR (NOW AZIYO BIOLOGICS) MODEL # CMCV-072-606; LOT #: UNKNOWN OFF-LABEL TO CREATE AN 8CM (6MM DIAMETER) TUBULAR BRIDGE GRAFT BETWEEN LATERAL CEPHALIC VEIN AND ANTEBRACHIAL CEPHALIC VEIN. AT 7 WEEKS POST-OP, STENOSIS OF THE CORMA

  Patient problems: Restenosis; Stenosis; Thrombosis/Thrombus

  MAUDE report 10744162 ↗
• InjuryOct 11, 2017Delamination; Delamination

  IT WAS REPORTED THAT AFTER OPENING THE BOX AND STERILE PACKAGE IT WAS OBSERVED THAT THE ECM WAS DELAMINATED. ANOTHER ONE WAS OPENED AND USED WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION WAS REQUESTED ON 8/8/2017. ADDITIONAL INFORMATION RECEIVED ON 9/14/2017 THAT STATES, "ON (B)(6) 2017 AN AORTIC REPAIR WAS COMPLETED ON A (B)(6) MALE. THE ECM WAS NOT HYDRATED IN ANY SOLUTION AND ONLY THE PATIENTS' BLOOD WAS USED. DURING SUTURING OF THE PATCH DELAMINATION WAS OBSERVED. THE ECM WAS REMOVED AND THE PATCH WAS CHANGED." IT WAS STATED THAT THE SURGICAL TIME WAS PROLONGED (BUT DID NOT STATE SIGNIFICANTLY). THE FINAL OUTCOME OF THE PATIENT WAS GOOD WITH NO COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6941250 ↗