Hemashield M00202175928P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00384401018650), received between Aug 22, 2018 and Jun 4, 2025 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (5 reports).

20 other recalls cover devices cleared under the same FDA submission (K021213); 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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Nonstandard Device; Product Quality Problem; Nonstandard Device; Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR THAT DURING THE PREPARATION FOR THE SURGERY, A DISCOLORATION WAS FOUND ON A PART OF THE PRODUCT LIKELY DUE TO THE MELTING OF COLLAGEN. THE SURGERY WAS COMPLETED WITH A HEMASHIELD 4-BRANCH (REF. M00202175926P0, SN (B)(6) AVAILABLE AT THE HOSPITAL, AND IT HAD NO EFFECT ON THE PATIENT'S CONDITION OR THE SURGICAL PROCEDURE. THE INVOLVED PRODUCT IS AVAILABLE FOR EXAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140598 ↗
• MalfunctionOct 7, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381438 ↗
• InjuryMar 23, 2023Product Quality Problem; Product Quality Problem

  COMPLAINT #(B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16602731 ↗
• InjuryMar 21, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR THAT : "TOTAL ARCH GRAFT REPLACEMENT WAS PERFORMED WITH TYPE A DISSECTION, AND DURING CPB WEANING, OVERALL OOZING OCCURRED IN THE GRAFT, MAKING IT DIFFICULT TO DIFFERENTIATE THE BLEEDING OF THE SURGICAL ANASTOMOSIS SITE. AFTER CPB WAS TURNED OFF AND PROTAMINE AND PLATELET FFP WERE TRANSFUSED, OOZING STOPPED. THE GRAFT IS CURRENTLY IMPLANTED IN THE PATIENT." A VIDEO FILE OF THE OPERATION WAS ATTACHED. IT WAS ADDITIONALLY REPORTED THAT DURING CPB WEAVING, OOZING OCCURRED IN THE GRAFT IN GENERAL AND NOT JUST ONE PART OF THE BRANCH. IT TOOK ABOUT 3-40 MINUTES TO STOP OOZING AFTER CPB OFF AND BLOOD TRANSFUSION SUCH AS PROTEIN AND PLATELET FFP. PLATELET TRANSMISSION WAS PERFORMED AFTER BLEEDING THROUGHOUT THE GRAFT IN THE PROCESS OF BLOOD CIRCULATION THROUGH HEART PUMPING AFTER REMOVING THE CARDIOPULMONARY SYSTEM. MOREOVER, THERE WAS NO REPORTED CONSEQUENCES ON THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16581925 ↗
• MalfunctionMar 3, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT: " PROFESSOR (B)(6) OF THORACIC SURGERY, (B)(6) MEDICAL CENTER, (B)(6) HOSPITAL WHILE PREPARING FOR SURGERY, STAINS WERE FOUND ON THE GRAFT, SO IT WAS NOT USED." NO ADVERSE EVENT WAS REPORTED, THE SURGERY WAS NOT DELAYED. COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13658022 ↗
• MalfunctionJul 27, 2021Inaccurate Information; Inaccurate Information

  SEE MFG REPORT(S) # 1640201-2021-00026. COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232633 ↗
• InjuryApr 21, 2021Nonstandard Device; Use of Device Problem; Nonstandard Device; Use of Device Problem

  MASSIVE BLEEDING OCCURRED FROM THE GRAFT BODY. A LOT OF BLEEDING OCCURRED FOR AN HOUR. DURING BLEEDING, PATIENT BLOOD PRESSURE WAS 40~50MMHG. THE PATIENT RECEIVED A BLOOD TRANSFUSION. TO STOP BLEEDING, THE GRAFT BODY WAS WRAPPED WITH DACRON GRAFT AND STOPPED BLEEDING FOR MORE THAN 20 MINUTES WITH GAUZE AND THE PROCEDURE WAS COMPLETED. THE GRAFT IS IMPLANTED IN THE PATIENT AND IT WILL NOT BE RETURNED. PROCEDURE DETAILS: EXTENT II THORACOABDOMINAL AORTIC REPLACEMENT. ON (B)(6) 2020, FIRST SURGERY: REDO BENTALL OP (AORTIC VALVE & TOTAL ARCH REPLACEMENT). SINCE THE PATIENT WAS WITH THORACIC AORTIC ANEURYSM, THORACOABDOMINAL AORTA REPLACEMENT SURGERY WAS ALSO REQUIRED. THE MEDICAL STAFF DETERMINED THAT THESE TWO SURGERIES AT A TIME COULD MAKE THE PATIENT IN DANGER. REDO BENTALL OP (AORTIC VALVE & TOTAL ARCH REPLACEMENT) WAS PLANNED AT FIRST. HEMASHIELD 4-BRANCH 28MM WAS USED AND ELEPHANT TRUNK WAS PLACED INSIDE THE DESCENDING THORACIC AORTA. HEMASHIELD DISTAL JUST LAID OUT THE ELEPHANT TRUNK ON THE DESCENDING AORTA WITH ANEURYSM WITHOUT ANASTOMOSIS. ON 6 AUGUST 2020, RE-LAPAROTOMY: AFTER ANASTOMOSIS OF THE ELEPHANT TRUNK AND COSELI (VASCUTEK THORACOABDOMINAL 4-BRANCH 28MM) PUT INTO THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Paraplegia

  MAUDE report 11699266 ↗
• InjuryApr 20, 2021Nonstandard Device; Use of Device Problem; Nonstandard Device; Use of Device Problem

  MASSIVE BLEEDING OCCURRED FROM THE GRAFT BODY. A LOT OF BLEEDING OCCURRED FOR AN HOUR. DURING BLEEDING, PATIENT BLOOD PRESSURE WAS 40~50MMHG. THE PATIENT RECEIVED A BLOOD TRANSFUSION. TO STOP BLEEDING, THE GRAFT BODY WAS WRAPPED WITH DACRON GRAFT AND STOPPED BLEEDING FOR MORE THAN 20 MINUTES WITH GAUZE AND THE PROCEDURE WAS COMPLETED. THE GRAFT IS IMPLANTED IN THE PATIENT AND IT WILL NOT BE RETURNED. PROCEDURE DETAILS: EXTENT II THORACOABDOMINAL AORTIC REPLACEMENT. ON (B)(6) 2020, FIRST SURGERY: REDO BENTALL OP (AORTIC VALVE & TOTAL ARCH REPLACEMENT). SINCE THE PATIENT WAS WITH THORACIC AORTIC ANEURYSM, THORACOABDOMINAL AORTA REPLACEMENT SURGERY WAS ALSO REQUIRED. THE MEDICAL STAFF DETERMINED THAT THESE TWO SURGERIES AT A TIME COULD MAKE THE PATIENT IN DANGER. REDO BENTALL OP (AORTIC VALVE & TOTAL ARCH REPLACEMENT) WAS PLANNED AT FIRST. HEMASHIELD 4-BRANCH 28MM WAS USED AND ELEPHANT TRUNK WAS PLACED INSIDE THE DESCENDING THORACIC AORTA. HEMASHIELD DISTAL JUST LAID OUT THE ELEPHANT TRUNK ON THE DESCENDING AORTA WITH ANEURYSM WITHOUT ANASTOMOSIS. ON (B)(6) 2020, RE-LAPAROTOMY: AFTER ANASTOMOSIS OF THE ELEPHANT TRUNK AND COSELI (VASCUTEK THORACOABDOMINAL 4-BRANCH 28MM) PUT INTO THE EX

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Paraplegia

  MAUDE report 11692766 ↗
• MalfunctionFeb 7, 2020Product Quality Problem; Product Quality Problem

  SEE INITIAL MFR REPORT #1640201-2020-00003. COMPLAINT # (B)(4) CORRECTED DATA: FOLLOWING CLARIFICATION, THE EVENT IS DESCRIBED AS FOLLOWS: WHEN THE CUSTOMER OPENED THE PRODUCT, THEY FOUND THERE WAS YELLOW BLOT ON SURFACE OF THE GRAFT.

  Patient problems: No Patient Involvement

  MAUDE report 9680453 ↗
• InjuryAug 22, 2018Material Puncture/Hole; Material Puncture/Hole

  DURING SURGERY FOR ANEURYSMAL DISEASE, THE GRAFT HAS A SERIOUS HOLE BLEEDING PROBLEM. THERE WAS NO TRANSFUSION DURING THE SURGERY. SURGEON USED DRUGS AS NOVOSEVEN AND BIOGLUE TO STOP THE BLEEDING. THE PATIENT REMAINED IMPLANTED AND STABLE.

  Patient problems: Blood Loss

  MAUDE report 7805508 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021213. One submission often covers many models, so check the product and lot details in each record.

• Z-1871-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1874-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1877-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1881-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• Z-1875-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1880-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1876-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1873-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• Z-1870-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• Z-1864-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected wit
• Z-1866-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury
• Z-1869-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• Z-1868-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• Z-1867-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement or repair of arteries affected with aneur
• Z-1878-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Product Usage: for use in the replacement or repair of arteries affected with aneury

…and 5 more.