FDA-Device2021-06-23Class II
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Hazard
Specific lots may have been manufactured with insufficient or incomplete welds.
Sold states
US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
Affected count
14 tubing packs
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1883-2021More Medtronic Perfusion Systems recalls
- FDA-Device2026-07-01Medtronic Octopus Evolution AS Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus 4 Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus Evolution Tissue Stabilizer recalled for incorrect tubing assembly
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
- FDA-Device2026-05-27Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
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