EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return
Summary
The FDA issued a Class II for EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with card by Medtronic Perfusion Systems. Reason: Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, .
Details
Source
Device Recall
External ID
Z-2807-2026
Action Date
2026-08-05
Status
Ongoing
Category
device
Product Description
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
Lot/Code Info: UDI-DI: 00199150023288, Lot Numbers: 0233286436; UDI-DI: 20199150023282, Lot Numbers: 0232709428 0232744924 0232745061 0232745092 0232798556 0232862763 0232862778 0232862794 0232862798 0232903216 0232903291 0232903383 0232990983 0233286318 0233286414 0233286436 0233427120 0233528730 0233553623 0233556386 0233585113 0233585114 0232670802
Quantity Affected: 11,720 units
Reason for Recall
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-24
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 136 device recalls issued in the same week, part of 341 device-related FDA actions this month.
Medtronic Perfusion Systems has 61 FDA actions in our database, including 60 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 61 FDA actions in our database, including 60 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2807-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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