Medtronic DLP Retrograde Cannula Recall: Sterile Barrier Breach Risk
Medtronic recalls specific lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94725) due to potential sterile barrier breach. Affected units may pose infection risks during medical procedures.
Lower-risk recall
Certain lots of product have the potential for a sterile barrier breach.
Contact the company
What happened, in plain English
Medtronic is recalling certain lots of DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94725) because they may have a sterile barrier breach. This could lead to infection risks during medical procedures if used improperly. Read more at govinfonow.com/recall/49409-medtronic-dlp-retrograde-cannula-recall-sterile-barrier-breach-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/49409-medtronic-dlp-retrograde-cannula-recall-sterile-barrier-breach-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2218-2026
Cite this page
“Medtronic DLP Retrograde Cannula Recall: Sterile Barrier Breach Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49409-medtronic-dlp-retrograde-cannula-recall-sterile-barrier-breach-risk. Based on FDA recall #Z-2218-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2218-2026%22&limit=1).
Why it’s dangerous
The sterile barrier breach could allow contaminants to enter the bloodstream during surgery, potentially causing infections. This risk is specific to medical procedures involving the cardiovascular system.
Who’s affected
Patients undergoing cardiopulmonary bypass surgery who use this specific cannula model are most at risk. Healthcare providers using the recalled lots during procedures may also be affected.
How to tell if you have this one
Check for the model number 94725 on the silicone body. Look for lot numbers listed: 0231650787, 0231758255, 0231862812, C231966207, and others as specified in the recall notice.
- Brand
Medtronic- Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular- Category
Medical device
All 9 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2214-2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter; GTIN 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 units |
| Z-2215-2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter; GTIN 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 units |
| Z-2216-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter; GTIN 20643169454556, Lot Numbers: 0231881762, 0231881786, 0231931962, 0231962106, C233032040. | 600 units |
| Z-2217-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter; GTIN 00643169454705, Lot Numbers: 0231823435, 0231961203; GTIN 20643169454709, Lot Numbers: 0231823435, 0231823478, 0231961203. | 840 units |
| Z-2218-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter; GTIN 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 units |
| Z-2219-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter; GTIN 20643169454785, Lot Numbers: 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262, 0231772525, 0231792898, 0232066774, 0232112345, 0232114667, C232276641, C232277146, C232277149, C232949860, C232949864. | 3210 units |
| Z-2220-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter; GTIN 00643169454460, Lot Numbers: 0231665646; GTIN 20643169454464, Lot Numbers: 0231665646, 0231665648. | 481 units |
| Z-2221-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter; GTIN 20643169454808, Lot Numbers: 0231859673. | 280 units |
| Z-2222-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter; GTIN 20643169454815, Lot Numbers: 0231665658, C231786900. | 260 units |
What to do — step by step
Check Product Details
Identify the model number (94725) and lot numbers listed in the recall notice to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2218-2026 (April 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2218-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.