CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch SGPH00Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K101866); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 28, 2024Class IIOpen, Classified

   Grafts were found to have been approved, released, shipped and implanted with an invalid test results.

   Z-2532-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101866. One submission often covers many models, so check the product and lot details in each record.

• Z-0653-2021 · Nov 10, 2020 · Terminated
  CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging
• Z-2272-2018 · May 14, 2018 · Terminated
  Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
• Z-0809-2014 · Nov 22, 2013 · Terminated
  Pulmonary Hemi-Artery SG Used in heart surgery
• Z-1561-2011 · Feb 17, 2011 · Terminated
  Pulmonary Hemi-Artery SG Used in heart surgery