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Limited official informationFDA Medical Device Enforcement ReportsRecall date: May 27, 2026

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725

Full official product description

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter

Verification delayed

The last verified facts remain visible. Last successful verification: Jul 30, 2026, 10:43 PM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter; Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter; plus 7 additional official variants listed below.

Identifiers to compare

  • Model 94725
  • Model 94913
  • Model 94215T
  • Model 94113T
  • Model 94665
  • Model 94915
  • Model 94965
  • Model 94913L
  • Model 94115T
  • Lot Numbers
  • Lot 0231758255
  • Lot 0231862812
  • Lot C231966207
  • Lot 0231650793
  • Lot 0231758250
  • Lot 0231758279
  • Lot 0231758282
  • Lot 0231823523
  • Lot 0231937422
  • Lot C23196572
  • Lot 0231757978
  • Lot 0231757985
  • Lot 0231758246
  • Lot 0231758249
  • Lot 0231758254
  • Lot 0231758262
  • Lot 0231772525
  • Lot 0231792898
  • Lot 023206677
  • Lot 0231881786
  • Lot 0231931962
  • Lot 0231962106
  • Lot C233032040
  • Lot 0231651345
  • Lot 0231651385
  • Lot 0231651389
  • Lot 0231651396
  • Lot 0231667029
  • Lot 0231667046
  • Lot 0231757975
  • Lot 0231758248
  • Lot 023175825
  • Lot 0231961203
  • Lot 0231823478
  • Lot C231786900
  • Lot 0231665648
  • Lot C231958117
  • Lot 0231545560
  • Lot 0231545565
  • Lot 0231545567
  • Lot 0231545569
  • Lot 0231592142
  • Lot 0231592228
  • Lot 0231592241
  • Lot 0231665664
  • Lot 023166570

9 official variants

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheterGTIN 00643169454736, Lot Numbers: 0231650787, 0231758255, 0231862812, C231966207; GTIN 00673978188713, Lot Numbers: 0231937422; GTIN 20643169454730, Lot Numbers: 0231650787, 0231650793, 0231758250, 0231758255, 0231758279, 0231758282, 0231823523, 0231862812, 0231937422, C231965721, C231966207, C232428221, C232430086.2620 unitsZ-2218-2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheterGTIN 20643169454785, Lot Numbers: 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262, 0231772525, 0231792898, 0232066774, 0232112345, 0232114667, C232276641, C232277146, C232277149, C232949860, C232949864.3210 unitsZ-2219-2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheterGTIN 20643169454556, Lot Numbers: 0231881762, 0231881786, 0231931962, 0231962106, C233032040.600 unitsZ-2216-2026
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheterGTIN 00673978188447, Lot Numbers: 0231651336; GTIN 20643169454877, Lot Numbers: 0231651336, 0231651345, 0231651385, 0231651389, 0231651396, 0231667029, 0231667046, 0231757975, 0231758248, 0231758259, 0231936467, 0231982226, 0232274424, C232287618, C232287619, C232287620, C232598550, C232598552.3790 unitsZ-2214-2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheterGTIN 00643169454705, Lot Numbers: 0231823435, 0231961203; GTIN 20643169454709, Lot Numbers: 0231823435, 0231823478, 0231961203.840 unitsZ-2217-2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheterGTIN 20643169454808, Lot Numbers: 0231859673.280 unitsZ-2221-2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheterGTIN 20643169454815, Lot Numbers: 0231665658, C231786900.260 unitsZ-2222-2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheterGTIN 00643169454460, Lot Numbers: 0231665646; GTIN 20643169454464, Lot Numbers: 0231665646, 0231665648.481 unitsZ-2220-2026
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheterGTIN 00643169454521, Lot Numbers: 0231545565, C231958117; GTIN 20643169454525, Lot Numbers: 0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716, 0231667178, 0231823613, 0231823689, 0231823700, 0231846134, 0231862819, 0231912810, C231958117, C231958118, C231958119, C231958120, C232287623.6572 unitsZ-2215-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Certain lots of product have the potential for a sterile barrier breach.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.
  • : affectedSummary changed in the official record.
  • : affectedSummary changed in the official record.
  • : affectedSummary changed in the official record.