Medtronic Pediatric Cannulae Recall: Incorrect Labeling Risk
Medtronic recalls specific pediatric arterial cannula models due to incorrect labeling in certain lots. Affected units may have labeling errors that could lead to improper use during medical procedures.
Lower-risk recall
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Contact the company
What happened, in plain English
Medtronic is recalling two specific pediatric arterial cannula models because they have incorrect labeling in certain production lots. This could lead to improper medical use if the wrong cannula is selected during procedures. Read more at govinfonow.com/recall/53306-medtronic-pediatric-cannulae-recall-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/53306-medtronic-pediatric-cannulae-recall-incorrect-labeling-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0984-2025
Cite this page
“Medtronic Pediatric Cannulae Recall: Incorrect Labeling Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53306-medtronic-pediatric-cannulae-recall-incorrect-labeling-risk. Based on FDA recall #Z-0984-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0984-2025%22&limit=1).
Why it’s dangerous
Incorrect labeling means healthcare providers might select the wrong cannula size for a patient, potentially causing complications during medical procedures. This risk is specific to the labeling error in certain production lots.
Who’s affected
Healthcare professionals using these cannulae for pediatric patients are most at risk. Patients receiving these cannulae during medical procedures may be affected if the labeling error leads to incorrect selection.
How to tell if you have this one
Check for model numbers 77008 (8 Fr) or 77014 (14 Fr) with specific lot numbers: 2024010723, 202404C049 for model 77008 and 2023121097 for model 77014.
- Brand
Medtronic Perfusion Systems- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0984-2025 | DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr); Model 77008 UDI-DI: 20763000091105, Lot Numbers: 2024010723, 202404C049; Model 77014 UDI-DI: 20763000091136, Lot Number: 2023121097 | 745 units |
| Z-0985-2025 | EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr); Model 77418 UDI-DI: 20763000135618, Lot Numbers: 2022041038; Model 77422 UDI-DI: 20643169485970, Lot Number: 2023020934 | 930 units |
| Z-0986-2025 | Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr); Model 72422 UDI-DI: 20643169485970, Lot Numbers: 2023071075, 202309C075 | 440 units |
What to do — step by step
Check Labeling
Verify the model number and lot number on the cannula to confirm if it matches the affected lots listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0984-2025 (December 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0984-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.