Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Summary
The FDA issued a Class II for Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Ca by Medtronic Perfusion Systems. Reason: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood..
Details
Source
Device Recall
External ID
Z-2738-2026
Action Date
2026-07-22
Status
Ongoing
Category
device
Product Description
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Lot/Code Info: MATNR A7630009466801/UDI/DI 20763000946689, Lot Numbers: 0231650870, C232227220
Reason for Recall
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Distribution
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-25
Company
Brooklyn Park, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 102 device recalls issued in the same week, part of 365 device-related FDA actions this month.
Medtronic Perfusion Systems has 55 FDA actions in our database, including 54 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Perfusion Systems) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Perfusion Systems have FDA actions?
Medtronic Perfusion Systems has 55 FDA actions in our database, including 54 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2738-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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