The Recall Desk
HighFDA (Devices)·Z-2219-2026·Announced 2026-05-27

Medtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall

Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94913), a cardiopulmonary bypass vascular catheter, due to a potential sterile barrier breach.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall involving a sterile barrier breach in a critical cardiopulmonary bypass catheter represents a risk of serious harm to patients if the breach allows contamination during cardiac surgery, even though no reported illnesses or injuries are stated in the source text.

Plain-English summary

Medtronic Perfusion Systems is recalling certain lots of the Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR (Model 94913), a cardiopulmonary bypass vascular catheter. The affected product has the potential for a sterile barrier breach.

Affected lot numbers are: 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262, 0231772525, 0231792898, 0232066774, 0232112345, 0232114667, C232276641, C232277146, C232277149, C232949860, and C232949864. A total of 3,210 units have been distributed worldwide, including nationwide in the United States and internationally to Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.

Healthcare providers using the affected lots should review their inventory and contact Medtronic for instructions on product handling and replacement options. The FDA has classified this recall as Class II.

The recalled product

Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiopulmonary Bypass Catheter
Hazard
Affected units
3,210

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • GTIN 20643169454785
  • Lot Numbers: 0231757977
  • 0231757978
  • 0231757985
  • 0231758246
  • 0231758249
  • 0231758254
  • 0231758262
  • 0231772525
  • 0231792898
  • 0232066774
  • 0232112345
  • 0232114667
  • C232276641
  • C232277146
  • C232277149
  • C232949860
  • C232949864.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · sterile barrier breach

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