FDA-Device2025-01-29Class II
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Hazard
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Sold states
Worldwide - US Nationwide distribution.
Affected count
745 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0984-2025More Medtronic Perfusion Systems recalls
- FDA-Device2026-07-22Medtronic Bio-Medicus Adult Cannula Kit recalled for loose foreign material with blood
- FDA-Device2026-07-22Medtronic DLP One-Piece Pediatric Arterial Cannula recalled for loose foreign material with blood
- 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
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