Hemashield M002000196240Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00384401018810), received between Oct 21, 2024 and Nov 6, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (10 reports).

2 other recalls cover devices cleared under the same FDA submission (K955349); 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.

• MalfunctionNov 6, 2024Product Quality Problem; Product Quality Problem

  COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618946 ↗
• MalfunctionOct 21, 2024Product Quality Problem; Product Quality Problem

  COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493620 ↗
• MalfunctionOct 21, 2024Product Quality Problem; Product Quality Problem

  COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493611 ↗
• MalfunctionOct 21, 2024Product Quality Problem; Product Quality Problem

  COMPLAINT #(B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493467 ↗
• MalfunctionOct 21, 2024Product Quality Problem; Product Quality Problem

  COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493455 ↗
• MalfunctionOct 21, 2024Product Quality Problem; Product Quality Problem

  COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493396 ↗
• MalfunctionOct 21, 2024Product Quality Problem; Product Quality Problem

  COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493388 ↗
• MalfunctionOct 21, 2024Product Quality Problem; Product Quality Problem

  COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493382 ↗
• MalfunctionOct 21, 2024Product Quality Problem; Product Quality Problem

  COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493286 ↗
• MalfunctionOct 21, 2024Product Quality Problem; Product Quality Problem

  COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20492822 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955349. One submission often covers many models, so check the product and lot details in each record.

• Z-1172-2018 · Jan 3, 2018 · Terminated
  HEMASHIELD Knitted Double Velour Cardiovascular Fabric
• Z-2062-2010 · May 24, 2010 · Terminated
  Hemashield Double Velour Cardiovascular Fabrics.