Hemacarotid Patch HEK08/75CPUT (1)Recalls & reported problems
Intervascular Sas · Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00384401001478), received between Feb 9, 2016 and Jul 30, 2025 — classified as 3 injuries, 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Manufacturing, Packaging or Shipping Problem2
- Nonstandard Device1
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
- Blood Loss1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED TO INTERVASCULAR THAT AN EXCESSIVE SUTURE HOLE BLEEDING WAS NOTICED WHILE IMPLANTING AND SUTURING A HEMACAROTID PATCH ULTRATHIN 8X75MM USING PROLENE 6-0 C1 SUTURE AND NEEDLE. THE BLEEDING WAS CONTROLLED USING PROTAMINE, TACHOSIL AND BY ALLOWING TIME FOR BLEEDING TO STOP.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22575965 ↗MalfunctionMar 2, 2020Nonstandard Device; Nonstandard Device
COMPLAINT (B)(4). EVENT DESCRIPTION: THE SURGEON ASKED FOR A CAROTID PATCH OF 8M, THE NURSE SUGGESTED THE HEK08/75CPUT. WHEN HE TOOK THE PATCH IN HAND HE REALIZED THAT IT WAS NOT THE RIGHT SIZE (WIDER (ABOUT 11 OR 12 MM)). HE CUT OUT A PIECE OF THE PATCH AND SET IT ASIDE FOR TESTING. NOTE THAT THE SAMPLE IS CLEAN. HE USED THE REST OF THE PATCH FOR THE PATIENT. NOTE THAT THE SURGEON HAD TO RE-CUT THE PATCH WHEREAS HE USUALLY USES 8 MM PATCHES BECAUSE HE DOES NOT WANT TO RETOUCH AND CUT THE PATCH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9775441 ↗MalfunctionJul 5, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE ITEM HAS ARRIVED MOIST IN THE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 6685496 ↗InjuryFeb 9, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING A SURGERY PERFORMED ON (B)(6) 2015, 30 MINUTES AFTER A THROMBOENDARTERECTOMY INTERVENTION OF THE LEFT CAROTID WITH PLACEMENT OF THE PATCH, THE WOUND HAD TO BE REOPENED BECAUSE OF MULTIPLE SOURCES OF BLEEDING. THIS REQUIRED THE USE OF HEMOSTATIC AGENTS, AND THE SURGERY WAS PROLONGED BY AN UNKNOWN AMOUNT OF TIME. THE PATCH REMAINED IMPLANTED.
Patient problems: Blood Loss
MAUDE report 5418534 ↗
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.