CryoPatch® SG Pulmonary Human Cardiac Branch Patch SGP020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00877234000485), received between Sep 18, 2025 and Sep 18, 2025 — classified as 1 injury.

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

3 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 ↗

2. Nov 10, 2020Class IITerminated

   On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.

   Z-0653-2021 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

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.

• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON (B)(6) 2025, THE RETURNED IMPLANT SUMMARY CARD IS MARKED TO INDICATE THAT AN ARTIVION GRAFT WAS EXPLANTED ON (B)(6) 2025. A QUERY OF THE IMPLANT DATABSE PROVIDED SGP020 SERIAL NUMBER: (B)(6) THAT WAS IMPLANTED ON (B)(6) 2023. ADDITIONAL INFORMATION FROM THE HOSPITAL RELAYED A RV TO PA CONDUIT REPLACEMENT WAS PERFORMED. AN ANEURYSM BELOW THE CONDUIT WAS THE INDICATION. THE ANEURYSM DID NOT INVOLVE THE CONDUIT. GRAFT WAS NOT SAVED FOR EVALUATION. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION FORTHCOMING. THIS INVESTIGATION IS RELEGATED TO SGP020 SERIAL NUMBER: (B)(6) WITH THE ALLEGATION OF EXPLANT.

  Patient problems: Aneurysm

  MAUDE report 23085962 ↗

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-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