Hemashield M002000195140Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401017899), received between Oct 31, 2018 and Oct 31, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (2 reports).

1 FDA recall record name this device's identifier.

1 other recall 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.

Recalls naming this device

1. Jan 3, 2018Terminated

   A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).

   Z-1172-2018 · Root cause: Labeling mix-ups · FDA record ↗

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.

• MalfunctionOct 31, 2018Product Quality Problem; Product Quality Problem

  DURING A CAROTID ENDARTERECTOMY, A FIRST PATCH WAS IMPLANTED BUT LOOKED "MORE YELLOW" AND IT FELT "FUZZIER AND THICKER" THAN PREVIOUS USED PATCHES (SEE MANUFACTURER REPORT 1640201-2018-00021 FOR THIS FIRST INVOLVED DEVICE). THE SURGEON OPENED A SECOND BOX (STERILE PACK REMAINED CLOSED) WITH A DIFFERENT LOT NUMBER. THIS SECOND PATCH LOOKED THE SAME AND IS THE SUBJECT OF THE PRESENT REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 8024893 ↗
• MalfunctionOct 31, 2018Product Quality Problem; Product Quality Problem

  DURING A CAROTID ENDARTERECTOMY, UPON OPENING OF THE PATCH, IT LOOKED "MORE YELLOW" AND IT FELT "FUZZIER AND THICKER" THAN PREVIOUS USED PATCHES. THIS FIRST PATCH REMAINED IMPLANTED. NO CONSEQUENCES OR IMPACT TO PATIENT. THE SURGEON OPENED ANOTHER BOX (STERILE PACK REMAINED CLOSED) WITH A DIFFERENT LOT NUMBER BUT IT LOOKED THE SAME. THIS SECOND PATCH IS AVAILABLE FOR INVESTIGATION (SEE MANUFACTURER REPORT 1640201-2018-00022 FOR THIS SECOND INVOLVED DEVICE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8024891 ↗

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-2062-2010 · May 24, 2010 · Terminated
  Hemashield Double Velour Cardiovascular Fabrics.