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FDA recall, , Moderate risk

Medtronic Gundry and DLP Retrograde Cannulas

Medtronic retrograde cannulas may have a sterile barrier breach.

Summary by Recall Canary from the FDA notice

What happened

Medtronic Perfusion Systems of Brooklyn Park, Minnesota, recalled certain lots of its Medtronic DLP and GUNDRY Retrograde Cannulas, Manual-Inflate Silicone Body models in 13FR and 15FR sizes, because the products have the potential for a sterile barrier breach. The recall began April 21, 2026, and was added to the FDA's Enforcement Report on May 20, 2026. The products were distributed nationwide and worldwide, including to countries such as Australia, Canada, Japan, and the United Kingdom.

More sterility problem 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?

9 products

Affected if its UDI-DI and lot code are listed under that product.

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

  1. Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter

    UDI-DI
    • 00643169454736
    • 0231650787
    • 0231758255
    • 0231862812
    • 00673978188713
    • 0231937422
    • 20643169454730
    • 0231650793
    • 0231758250
    • 0231758279
    • 0231758282
    • 0231823523
    Lot code
    • C231966207
    • C231965721
    • C232428221
    • C232430086

  2. Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter

    UDI-DI
    • 20643169454785
    • 0231757977
    • 0231757978
    • 0231757985
    • 0231758246
    • 0231758249
    • 0231758254
    • 0231758262
    • 0231772525
    • 0231792898
    • 0232066774
    • 0232112345
    • 0232114667
    Lot code
    • C232276641
    • C232277146
    • C232277149
    • C232949860
    • C232949864

  3. Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter

    UDI-DI
    • 20643169454556
    • 0231881762
    • 0231881786
    • 0231931962
    • 0231962106
    Lot code
    • C233032040

  4. Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter

    UDI-DI
    • 00673978188447
    • 0231651336
    • 20643169454877
    • 0231651345
    • 0231651385
    • 0231651389
    • 0231651396
    • 0231667029
    • 0231667046
    • 0231757975
    • 0231758248
    • 0231758259
    • 0231936467
    • 0231982226
    • 0232274424
    Lot code
    • C232287618
    • C232287619
    • C232287620
    • C232598550
    • C232598552

  5. Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter

    UDI-DI
    • 20643169454808
    • 0231859673

  6. Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter

    UDI-DI
    • 00643169454705
    • 0231823435
    • 0231961203
    • 20643169454709
    • 0231823478

  7. Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter

    UDI-DI
    • 20643169454815
    • 0231665658
    Lot code
    • C231786900

  8. Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter

    UDI-DI
    • 00643169454460
    • 0231665646
    • 20643169454464
    • 0231665648

  9. Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter

    UDI-DI
    • 00643169454521
    • 0231545565
    • 20643169454525
    • 0231545557
    • 0231545560
    • 0231545567
    • 0231545569
    • 0231592142
    • 0231592228
    • 0231592241
    • 0231665664
    • 0231665707
    • 0231665708
    • 0231665711
    • 0231665712
    • 0231665713
    • 0231665714
    • 0231665715
    • 0231665716
    • 0231667178
    • 0231823613
    • 0231823689
    • 0231823700
    • 0231846134
    • 0231862819
    • 0231912810
    Lot code
    • C231958117
    • C231958118
    • C231958119
    • C231958120
    • C232287623

Recall details

Company began the recall
Sold in

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.

Company
Medtronic Perfusion SystemsBrooklyn Park, Minnesota
Hazard
Sterility problem
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
98786
Recall numbers
Z-2214-2026 to Z-2222-2026

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)