FDA-Device2026-07-22Class IIPROCESSING DEFECT
Medtronic DLP One-Piece Pediatric Arterial Cannula recalled for loose foreign material with blood
What this means
Medtronic received two complaints of loose foreign material inside the DLP One-Piece Pediatric Arterial Cannula (Product Number 77010), a tube used during heart-lung bypass surgery in children. Testing confirmed the material contained trace levels of blood. No injuries have been reported.
- If you use or manage this device, contact Medtronic immediately for guidance on affected lot numbers 0231650870 and C232227220.
- Check your facility's inventory against the lot numbers listed in this recall.
- Do not use affected units until you receive further instructions from Medtronic.
The agency's original wording
Hazard
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Intended for
Children
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2738-2026Want us to check the next one for you?
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