Medtronic Perfusion Systems: DLP Single Stage Venous Cannulae Recalled for Incorrect Component Type

Agency Publication Date: September 12, 2024

Summary

Medtronic Perfusion Systems is recalling 290 units of its DLP Single Stage Venous Cannulae with right angle metal tips (Model 67312) because some packages contain the wrong product. During manufacturing, the straight-tip version (Model 66118) was incorrectly placed into packages labeled for the right-angle metal-tip model. This error means medical professionals may find a cannula that does not match the expected shape and tip configuration during surgical procedures. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding this device.

Risk

The use of an incorrect cannula tip (straight instead of right-angle metal tip) can lead to delays in surgical procedures or improper placement within the venous system, potentially complicating heart-lung bypass surgery.

What You Should Do

Check your medical inventory for Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, specifically Reference (REF) Number 67312.
Verify if your product matches GTIN 20613994879329 and one of the following Lot Numbers: 2023090954 or 202312C065.
If you identify an affected unit, do not use the device and set it aside for return or replacement according to Medtronic's instructions.
Contact Medtronic Perfusion Systems at their Brooklyn Park, Minnesota location or through your local representative to coordinate the return of the affected product.
Healthcare providers who have used these devices should monitor patients according to standard clinical protocols.
For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Device Return

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medtronic DLP Single Stage Venous Cannulae with right angle metal tip

Model / REF:

REF 67312

67312

UPC Codes:

20613994879329

Lot Numbers:

2023090954

202312C065

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95152

Status: Active

Manufacturer: Medtronic Perfusion Systems

Sold By: Authorized medical distributors; Direct hospital sales

Manufactured In: United States

Units Affected: 290 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 · 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.

Summary

What You Should Do

Check your medical inventory for Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, specifically Reference (REF) Number 67312.

Verify if your product matches GTIN 20613994879329 and one of the following Lot Numbers: 2023090954 or 202312C065.

If you identify an affected unit, do not use the device and set it aside for return or replacement according to Medtronic's instructions.

Contact Medtronic Perfusion Systems at their Brooklyn Park, Minnesota location or through your local representative to coordinate the return of the affected product.

Healthcare providers who have used these devices should monitor patients according to standard clinical protocols.

For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.