Hemacarotid Patch HEK14/75CPUT (1)Recalls & reported problems
Intervascular Sas · Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401001508), received between Mar 19, 2022 and Mar 22, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K983819); 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Nonstandard Device2
- Patient Device Interaction Problem2
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 22, 2022Nonstandard Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Nonstandard Device; Insufficient Device Problem Information; Patient Device Interaction Problem
THE FOLLOWING INCIDENT WAS REPORTED TO INTERVASCULAR THAT POROSITY OF THE DEVICE OBSERVED AFTER THE PLACEMENT OF A CAROTID PATCH DURING THE INTERVENTION (LEFT INTERNAL CAROTID) AND THIS, AT A DISTANCE FROM THE PROLENE NEEDLES HOLES. BLEEDING WAS OBSERVED ACROSS THE "UNSEALED" PATCH. CONSEQUENCES: DIFFUSE BLEEDING DESPITE HEMOSTASIS; PROTAMINE AND MANUAL COMPRESSION BY THE OPERATOR ; EXTENSION OF INTERVENTIONAL AND ANESTHETIC TIMES; APPLICATION OF AN ADDITIONAL PATCH. ACTION(S) TAKEN: INJECTION OF PROTAMINE TO NEUTRALIZE THE HEPARIN ; MANUAL COMPRESSION FOR SEVERAL MINUTES TO ACHIEVE HEMOSTASIS ADDITION OF SURGICEL. THE PATCH HAS BEEN IMPLANTED AND ANOTHER ONE HAS BEEN ADDED. THE PRODUCT WILL NOT BE RETURNED FOR INSPECTION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 13845566 ↗InjuryMar 19, 2022Nonstandard Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Nonstandard Device; Insufficient Device Problem Information; Patient Device Interaction Problem
THE FOLLOWING INCIDENT WAS REPORTED TO INTERVASCULAR THAT POROSITY OF THE DEVICE OBSERVED AFTER THE PLACEMENT OF A CAROTID PATCH DURING THE INTERVENTION (LEFT INTERNAL CAROTID) AND THIS, AT A DISTANCE FROM THE PROLENE NEEDLES HOLES. BLEEDING WAS OBSERVED ACROSS THE "UNSEALED" PATCH. CONSEQUENCES: DIFFUSE BLEEDING DESPITE HEMOSTASIS; PROTAMINE AND MANUAL COMPRESSION BY THE OPERATOR ; EXTENSION OF INTERVENTIONAL AND ANESTHETIC TIMES; APPLICATION OF AN ADDITIONAL PATCH. ACTION(S) TAKEN: INJECTION OF PROTAMINE TO NEUTRALIZE THE HEPARIN ; MANUAL COMPRESSION FOR SEVERAL MINUTES TO ACHIEVE HEMOSTASIS ADDITION OF SURGICEL. THE PATCH HAS BEEN IMPLANTED AND ANOTHER ONE HAS BEEN ADDED. THE PRODUCT WILL NOT BE RETURNED FOR INSPECTION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 13822223 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K983819. One submission often covers many models, so check the product and lot details in each record.
- Z-0638-04 · Dec 30, 2003 · TerminatedHemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; H
Other Prosthesis, Vascular Graft, Of 6mm And Greater Diameter devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.