Hemacarotid Patch HEK14/75CP (1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401001454), received between May 6, 2026 and May 26, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K964625); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Off-Label Use; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information

  IT WAS REPORTED TO INTERVASCULAR THAT A CLASSIC ENDARTERECTOMY OF THE LEFT ATRIAL APPENDAGE IN A CARDIOVASCULAR RISK PATIENT WITH AN UNSTABLE PLAQUE OF THE LEFT ATRIAL APPENDAGE ON DUAL ANTIPLATELET THERAPY, AFTER SUTURING THE PROSTHETIC PATCH AND RELEASING THE CLAMPS, PROTAMINE WAS ADMINISTERED ACCORDING TO THE ADMINISTERED DOSE OF HEPARIN, THERE WAS SIGNIFICANT BLEEDING FROM THE PUNCTURES OF THE 6/0 FIBERS, BUT ESPECIALLY THE PATCH ITSELF (BETWEEN THE PORES), THE BLEEDING COULD NOT BE STOPPED FOR ABOUT 50 MINUTES, EVEN WITH THE USE OF 3X TACHOSIL, IT SHOULD BE ADDED THAT THE ADMINISTRATION OF ADDITIONAL PROTAMINE AT THE ORIGINAL FULL DOSE HAD NO EFFECT ON THE BLEEDING. NO HEALTH IMPACTED ON THE PATIENT ONLY PROLONGED PROCEDURE BY 50 MINUTES. THE PROCEDURE CONTINUED AND COMPLETED SUCCESSFULLY. THE PATIENT WAS ON ANTICOAGULATION: ANOPYRIN, TROMBEX, INTRAOPERATIVE HEPARIN, CANCELED WITH A FULL DOSE OF PROTAMINE, THEN 1/2 OF THE PREVIOUS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25275001 ↗
• InjuryMay 6, 2026Off-Label Use; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information

  IT WAS REPORTED TO INTERVASCULAR THAT A CLASSIC ENDARTERECTOMY OF THE LEFT ATRIAL APPENDAGE IN A CARDIOVASCULAR RISK PATIENT WITH AN UNSTABLE PLAQUE OF THE LEFT ATRIAL APPENDAGE ON DUAL ANTIPLATELET THERAPY, AFTER SUTURING THE PROSTHETIC PATCH AND RELEASING THE CLAMPS, PROTAMINE WAS ADMINISTERED ACCORDING TO THE ADMINISTERED DOSE OF HEPARIN, THERE WAS SIGNIFICANT BLEEDING FROM THE PUNCTURES OF THE 6/0 FIBERS, BUT ESPECIALLY THE PATCH ITSELF (BETWEEN THE PORES), THE BLEEDING COULD NOT BE STOPPED FOR ABOUT 50 MINUTES, EVEN WITH THE USE OF 3X TACHOSIL, IT SHOULD BE ADDED THAT THE ADMINISTRATION OF ADDITIONAL PROTAMINE AT THE ORIGINAL FULL DOSE HAD NO EFFECT ON THE BLEEDING. NO HEALTH IMPACTED ON THE PATIENT ONLY PROLONGED PROCEDURE BY 50 MINUTES. THE PROCEDURE CONTINUED AND COMPLETED SUCCESSFULLY. THE PATIENT WAS ON ANTICOAGULATION: ANOPYRIN, TROMBEX, INTRAOPERATIVE HEPARIN, CANCELED WITH A FULL DOSE OF PROTAMINE, THEN 1/2 OF THE PREVIOUS. COMPLAINT# (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25092695 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964625. One submission often covers many models, so check the product and lot details in each record.

• Z-1439-2010 · Dec 9, 2009 · Terminated
  InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K9842
• Z-1427-2010 · Dec 9, 2009 · Terminated
  InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in th