Hemashield M00202019579P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00384401017950), received between Mar 1, 2019 and Mar 1, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K962342); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE EVENT OCCURRED DURING PREPARATION FOR A PROCEDURE. UPON OPENING THE PACKAGE, THE PATCH WAS FOUND TO HAVE A "STICKY BROWN GUNK" DOWN THE MIDLINE. THERE WAS ENOUGH OF IT TO CONTAMINATE THE TECH'S GLOVES FROM TOUCHING THE PATCH. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8383489 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962342. One submission often covers many models, so check the product and lot details in each record.

• Z-1593-2011 · Dec 7, 2010 · Terminated
  Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic hepa
• Z-2064-2010 · May 24, 2010 · Terminated
  Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch.