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FDA recall, , Moderate risk

Medtronic EOPA Arterial Cannulas

Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass.

Summary by Recall Canary from the FDA notice

What happened

Medtronic Perfusion Systems, of Brooklyn Park, Minnesota, began a recall on June 24, 2026, for certain 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used as arterial return cannulae in cardiopulmonary bypass.

The agency stated that Medtronic received reports of pinhole leaks in the wire-wound body of these products, which may lead to hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. The recall was added to the FDA's Enforcement Report on July 27, 2026, and listed in the FDA's weekly enforcement report on August 5, 2026.

The affected products include EOPA Elongated One-Piece Arterial Cannula DIL Tip 22FR, EOPA Elongated One-Piece Arterial Cannula Blunt 22FR, EOPA 3D Arterial Cannula 22FR, and EOPA 3D Arterial Cannula DIL Tip 22FR. Distribution was worldwide, including nationwide in the US. The recall was classified by the FDA on July 27, 2026.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

6 products

Affected if its UDI-DI is listed.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. EOPA Elongated One-Piece Arterial Cannula DIL Tip 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722

    UDI-DI
    • 20199150023312
    • 0232657469
    • 0232670800
    • 0232744945
    • 0232798410
    • 0232862769
    • 0232985251
    • 0233116924
    • 0233116931
    • 00199150023318

  2. EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322

    UDI-DI
    • 20199150023251
    • 0232709184
    • 0232745036
    • 0232798416
    • 0232862784
    • 0232862787
    • 00199150023257

  3. EOPA 3D Arterial Cannula DIL Tip 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222

    UDI-DI
    • 20763000135700
    • 0232602300
    • 0232602383
    • 0232612916
    • 0232680078
    • 0232708967
    • 0232709001
    • 0232910880
    • 0232910881
    • 0232910882
    • 0233077983
    • 0233245850
    • 0233245860
    • 0233245980
    • 00763000135706

  4. EOPA Elongated One-Piece Arterial Cannula DIL Tip 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622

    UDI-DI
    • 20763000135670
    • 0232601501
    • 0232601510
    • 0232601549
    • 0232601550
    • 0232602178
    • 0232602290
    • 0232602302
    • 0232910952
    • 0232910953
    • 0232910954
    • 0232910955
    • 0233244075
    • 0233244301
    • 0233244531
    • 0233286362
    • 0233286374
    • 0233286390
    • 0233409034
    • 0233416071
    • 0233528731

  5. EOPA Elongated One-Piece Arterial Cannula Blunt 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422

    UDI-DI
    • 20763000135632
    • 0232446429
    • 0232446444
    • 0232486752
    • 0232601515
    • 0232601516
    • 0232601522
    • 0232601586
    • 0232601591
    • 0232601593
    • 0232602180
    • 0232798265
    • 0232798353
    • 0232849583
    • 0232894981
    • 0232895082
    • 0232902694
    • 0232902697
    • 0232902698
    • 0232902700
    • 0232902803
    • 0232902805
    • 0232902846
    • 0232985469
    • 0233009922
    • 0233108251
    • 0233116991
    • 0233127352
    • 0233334923
    • 0233334966
    • 0233426694
    • 0233426695
    • 0233528727
    • 00763000135638

  6. EOPA Elongated One-Piece Arterial Cannula Blunt 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522

    UDI-DI
    • 00199150023288
    • 0233286436
    • 20199150023282
    • 0232709428
    • 0232744924
    • 0232745061
    • 0232745092
    • 0232798556
    • 0232862763
    • 0232862778
    • 0232862794
    • 0232862798
    • 0232903216
    • 0232903291
    • 0232903383
    • 0232990983
    • 0233286318
    • 0233286414
    • 0233427120
    • 0233528730
    • 0233553623
    • 0233556386
    • 0233585113
    • 0233585114
    • 0232670802

Recall details

Company began the recall
Sold in

Worldwide - US Nationwide distribution.

Company
Medtronic Perfusion SystemsBrooklyn Park, Minnesota
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
99320
Recall numbers
Z-2806-2026 to Z-2811-2026

All recalls from Medtronic Perfusion Systems

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

More from this company

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)