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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medtronic Arterial Cannulae Recalled Due to Incorrect Labeling

Agency Publication Date: January 17, 2025
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Summary

Medtronic Perfusion Systems is recalling approximately 2,115 units of several arterial cannulae models, including DLP Pediatric One-Piece, EOPA, and Select Series Angled Tip models. These surgical devices are used during cardiac procedures and are being recalled because they were distributed with incorrect labeling. To date, no injuries or incidents have been reported in connection with this issue.

Risk

Incorrect labeling on surgical cannulae can lead to the use of the wrong size or type of device during critical perfusion procedures. This may result in surgical delays or unintended harm to the patient.

What You Should Do

  1. This recall affects DLP Pediatric One-Piece Arterial Cannulae (models 77008, 77014), EOPA Arterial Cannulae (models 77418, 77422), and Select Series Angled Tip Arterial Cannulae (model 72422).
  2. Check the device packaging for the following affected lot numbers: 2024010723, 202404C049, 2023121097, 2022041038, 2023020934, 2023071075, and 202309C075. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Medtronic Perfusion Systems or your authorized distributor to arrange for the return, replacement, or correction of the affected units.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: DLP Pediatric One-Piece Arterial Cannulae
Variants: 8 Fr, 14 Fr
Model / REF:
77008
77014
Lot Numbers:
2024010723
202404C049
2023121097
UDI:
20763000091105
20763000091136

Recall #: Z-0984-2025; Quantity: 745 units

Product: EOPA Arterial Cannula
Variants: 18 Fr, 22 Fr
Model / REF:
77418
77422
Lot Numbers:
2022041038
2023020934
UDI:
20763000135618
20643169485970

Recall #: Z-0985-2025; Quantity: 930 units

Product: Select Series Angled Tip Arterial Cannula
Variants: 22 Fr
Model / REF:
72422
Lot Numbers:
2023071075
202309C075
UDI:
20643169485970

Recall #: Z-0986-2025; Quantity: 440 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96015
Status: Active
Manufacturer: Medtronic Perfusion Systems
Sold By: Medtronic Perfusion Systems; Medical device distributors; Hospitals
Manufactured In: United States
Units Affected: 3 products (745 units; 930 units; 440 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.