Hemashield M00202175728AP0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401018728), received between Sep 12, 2022 and Sep 14, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS IS A CASE REPORT FROM LITERATURE OF A 71-YEAR-OLD FEMALE PATIENT WITH BEHCET'S DISEASE WHO HAD RECEIVED REPEATED SURGICAL AORTIC REPAIRS PRESENTED WITH A COMPLICATED PSEUDOANEURYSM.IT DEVELOPED NOT ON THE NATIVE AORTA, BUT ON THE ASCENDING AORTIC GRAFT. IT WAS POSITIONED JUST BESIDE THE OS OF THE ATTACHED TRIFURCATED VASCULAR GRAFT TRUNK CONNECTING ARCH VESSELS. TO AVOID REOPENING THE STERNUM, WHICH WOULD HAVE BEEN FATAL, COIL EMBOLIZATION WAS SUCCESSFULLY PERFORMED. THIS CASE SUGGESTS THAT TRANSCATHETER COIL EMBOLIZATION MIGHT PROVIDE AN ALTERNATIVE TREATMENT OPTION FOR SUCH PATIENTS WITH A HIGH RISK OF SURGICAL MORTALITY.THE REFERENCE OF THE ARTICLE IS THE FOLLOWING: KIM CH, SO YH, OK YJ, CHOI J-S. BAIL-OUT COIL EMBOLIZATION FOR A PSEUDOANEURYSM OF AORTIC SINOTUBULAR JUNCTION IN A PATIENT WITH BEHCET'S DISEASE AFTER RECEIVING MULTIPLE AORTIC OPERATIONS. J CARD SURG. 2022;37: 1410-1412.DOI:10.1111/JOCS.16304THE WEB ADDRESS LOCATION FOR THE ARTICLE IS THE FOLLOWING:HTTPS://PUBMED.NCBI.NLM.NIH.GOV/35148443/.THE ARTICLE WAS INITIALLY PUBLISHED ON JANVIER 23, 2022.

  Patient problems: Pseudoaneurysm

  MAUDE report 15422624 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS IS A CASE REPORT FROM LITERATURE OF A 71-YEAR-OLD FEMALE PATIENT WITH BEHCET'S DISEASE WHO HAD RECEIVED REPEATED SURGICAL AORTIC REPAIRS PRESENTED WITH A COMPLICATED PSEUDOANEURYSM. IT DEVELOPED NOT ON THE NATIVE AORTA, BUT ON THE ASCENDING AORTIC GRAFT. IT WAS POSITIONED JUST BESIDE THE OS OF THE ATTACHED TRIFURCATED VASCULAR GRAFT TRUNK CONNECTING ARCH VESSELS. TO AVOID REOPENING THE STERNUM, WHICH WOULD HAVE BEEN FATAL, COIL EMBOLIZATION WAS SUCCESSFULLY PERFORMED. THIS CASE SUGGESTS THAT TRANSCATHETER COIL EMBOLIZATION MIGHT PROVIDE AN ALTERNATIVE TREATMENT OPTION FOR SUCH PATIENTS WITH A HIGH RISK OF SURGICAL MORTALITY. THE REFERENCE OF THE ARTICLE IS THE FOLLOWING: KIM CH, SO YH, OK YJ, CHOI J-S. BAIL-OUT COIL EMBOLIZATION FOR A PSEUDOANEURYSM OF AORTIC SINOTUBULAR JUNCTION IN A PATIENT WITH BEHCET'S DISEASE AFTER RECEIVING MULTIPLE AORTIC OPERATIONS. J CARD SURG. 2022;37: 1410-1412. DOI:10.1111/JOCS.16304. THE WEB ADDRESS LOCATION FOR THE ARTICLE IS THE FOLLOWING:HTTPS://PUBMED.NCBI.NLM.NIH.GOV/35148443/. THE ARTICLE WAS INITIALLY PUBLISHED ON JANVIER 23, 2022.

  Patient problems: Pseudoaneurysm

  MAUDE report 15401106 ↗

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-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
• 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-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-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-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-1865-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected wit
• Z-1879-2020 · Apr 7, 2020 · Terminated
  HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - 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-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-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-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-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-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-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-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

…and 5 more.