Medtronic DLP Left Heart Vent Catheters: Wire Protrusion Risk
Medtronic recalls DLP Left Heart Vent Catheters (model 12118) with potential wire protrusion through the catheter tip. Affected units have specific lot numbers and expiration dates from 09/30/2020 to 05/19/2024.
Use caution until it’s fixed
Potential for a wire protrusion through the left heart vent catheter tip
Contact the company
What happened, in plain English
Medtronic is recalling DLP Left Heart Vent Catheters (model 12118) due to a potential wire protrusion through the catheter tip. This could cause serious complications during medical procedures. Read more at govinfonow.com/recall/61903-medtronic-dlp-left-heart-vent-catheters-wire-protrusion-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61903-medtronic-dlp-left-heart-vent-catheters-wire-protrusion-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2505-2021
Cite this page
“Medtronic DLP Left Heart Vent Catheters: Wire Protrusion Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61903-medtronic-dlp-left-heart-vent-catheters-wire-protrusion-risk. Based on FDA recall #Z-2505-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2505-2021%22&limit=1).
Why it’s dangerous
The catheter tip may have a wire that protrudes through the heart vent, potentially causing damage to the heart tissue or disrupting the procedure. This is a risk during medical procedures but not an immediate danger in normal use.
Who’s affected
Patients using these catheters for heart procedures and healthcare providers who have the specific model and lot numbers listed. Those with the affected units are at risk of complications.
How to tell if you have this one
Check for the model number 12118 and lot numbers listed in the expiration date range (09/30/2020 to 05/19/2024). The product is sold as sterile, prescription-only devices.
- Brand
Medtronic Perfusion Systems- Category
Medical device
All 2 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
Nationwide distribution to AL, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI. International distribution to Albania, Algeria, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Pakistan, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, Yemen.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2504-2021 | DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only; Model/Reference Number 12116, Lot Number (GTIN Number): 2018080039 (20643169086719), 2018091020 (20643169086719), 2018100911 (20643169086719), 2018111023 (20643169086719), 2018111419 (20643169086719), 2019120925 (20643169086719), 2018080039 (00673978462943), 2018091020 (00673978462943), 2018100911 (00673978462943), 2018111023 (00673978462943), 2018111419 (00673978462943), 2018120581 (20643169086719), 2018120581 (00673978462943), 2018120582 (20643169086719), 2018120582 (00673978462943), 2018121084 (20643169086719), 2018121084 (00673978462943), 2019010456 (20643169086719), 2019010456 (00673978462943), 2019010764 (20643169086719), 2019010764 (00673978462943), 2019020136 (20643169086719), 2019020136 (00673978462943), 2019020368 (20643169086719), 2019020368 (00673978462943), 2019020758 (20643169086719), 2019020758 (00673978462943), 2019030720 (20643169086719), 2019030720 (00673978462943), 2019031167 (20643169086719), 2019031167 (00673978462943), 2019040262 (20643169086719), 2019040262 (00673978462943), 2019040472 (20643169086719), 2019040472 (00673978462943), 2019040473 (20643169086719), 2019040473 (00673978462943), 2019041189 (20643169086719), 2019041189 (00673978462943), 2019050576 (20643169086719), 2019050576 (00673978462943), 2019060984 (20643169086719), 2019060984 (00673978462943), 2019071114 (20643169086719), 2019071114 (00673978462943), 2019090071 (20643169086719), 2019090071 (00673978462943), 2019091024 (20643169086719), 2019091024 (00673978462943), 2019100417 (20643169086719), 2019100417 (00673978462943), 2019101444 (20643169086719), 2019101444 (00673978462943), 2019111049 (20643169086719), 2019111049 (00673978462943), 2019120925 (00673978462943), 2020010368 (20643169086719), 2020010368 (00673978462943), 2020010445 (20643169086719), 2020010445 (00673978462943), 2020011619 (20643169086719), 2020011619 (00673978462943), 2020011620 (20643169086719), 2020011620 (00673978462943), 2020030064 (20643169086719), 2020030064 (00673978462943), 2020030848 (20643169086719), 2020030848 (00673978462943), 2020030849 (20643169086719), 2020030849 (00673978462943), 2020041429 (20643169086719), 2020041429 (00673978462943), 2020041430 (20643169086719), 2020041430 (00673978462943), 2020050078 (20643169086719), 2020050078 (00673978462943), 2020060672 (20643169086719), 2020060672 (00673978462943), 2020120078 (20643169086719), 2020120078 (00673978462943), 2020120619 (20643169086719), 2020120619 (00673978462943), 2021010032 (20643169086719), 2021010032 (00673978462943), 2021010552 (20643169086719), 2021010552 (00673978462943), 2021011167 (20643169086719), 2021011167 (00673978462943), 2021020486 (20643169086719), 2021020486 (00673978462943), 2021020985 (20643169086719), 2021020985 (00673978462943), 2018080040 (20643169086719), 2018090064 (20643169086719), 2018090434 (20643169086719), 2018091019 (20643169086719), 2018100118 (20643169086719), 2018100522 (20643169086719), 2018101295 (20643169086719), 2018101296 (20643169086719), 2018111418 (20643169086719), 2018111420 (20643169086719), 2018121083 (20643169086719), 201901C047 (20643169086719), 201901C048 (20643169086719), 201901C049 (20643169086719), 2019020759 (20643169086719), 201902C156 (20643169086719), 2019051126 (20643169086719), 201905C012 (20643169086719), 2019060218 (20643169086719), 2019060423 (20643169086719), 2019060686 (20643169086719), 201906C175 (20643169086719), 2019070713 (20643169086719), 2019081001 (20643169086719), 2019081291 (20643169086719), 2019091156 (20643169086719), 2019091157 (20643169086719), 2019100416 (20643169086719), 2019100731 (20643169086719), 2019101094 (20643169086719), 2019101445 (20643169086719), 2019110083 (20643169086719), 2019120089 (20643169086719), 2019120926 (20643169086719), 2020010369 (20643169086719), 2020020093 (20643169086719), 2020020470 (20643169086719), 2020020471 (20643169086719), 2020020763 (20643169086719), 2020030850 (20643169086719), 2020031186 (20643169086719), 2020040402 (20643169086719), 2020040762 (20643169086719), 2020050352 (20643169086719), 2020050699 (20643169086719), 2020050918 (20643169086719), 2020060963 (20643169086719), 2020070653 (20643169086719), 2020070654 (20643169086719), 2020070967 (20643169086719), 2020070968 (20643169086719), 2020071272 (20643169086719), 2020080074 (20643169086719), 2020080408 (20643169086719), 2020080409 (20643169086719), 2020080715 (20643169086719), 2020081032 (20643169086719), 2020081033 (20643169086719), 2020090631 (20643169086719), 2020100785 (20643169086719), 2020101109 (20643169086719), 2020110380 (20643169086719), 202011C197 (20643169086719), 202011C243 (20643169086719), 202011C244 (20643169086719), 2021010033 (20643169086719), 2021010034 (20643169086719), 2021011166 (20643169086719), 2021020487 (20643169086719), 2021020798 (20643169086719), 2021020986 (20643169086719), 2021020987 (20643169086719), 202102C091 (20643169086719), 202102C092 (20643169086719), 202102C093 (20643169086719), 2021030719 (20643169086719), 2021030720 (20643169086719), 2021031307 (20643169086719), 2021040872 (20643169086719), 2021041147 (20643169086719), 2021041148 (20643169086719), 2021050634 (20643169086719), 202105C140 (20643169086719), 202105C141 (20643169086719), 202105C142 (20643169086719), 202106C025 (20643169086719). Expiration date range: 09/30/2020 - 05/19/2024 | 51,494 units |
| Z-2505-2021 | DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only; Model/Reference Number 12118, Lot Number (GTIN Number): 2018080452 (20643169086702), 2018080452 (00673978462950), 2018090435 (20643169086702), 2018090435 (00673978462950), 2018100525 (20643169086702), 2018100525 (00673978462950), 2018111024 (20643169086702), 2018111024 (00673978462950), 2018111421 (20643169086702), 2018111421 (00673978462950), 2019020369 (20643169086702), 2019020369 (00673978462950), 2019030426 (20643169086702), 2019030426 (00673978462950), 2019031168 (20643169086702), 2019031168 (00673978462950), 2019041190 (20643169086702), 2019041190 (00673978462950), 2019060424 (20643169086702), 2019060424 (00673978462950), 2019070714 (20643169086702), 2019070714 (00673978462950), 2019070715 (20643169086702), 2019070715 (00673978462950), 2019080686 (20643169086702), 2019080686 (00673978462950), 2019081292 (20643169086702), 2019081292 (00673978462950), 2019090394 (20643169086702), 2019090394 (00673978462950), 2019091081 (20643169086702), 2019091081 (00673978462950), 2019100159 (20643169086702), 2019100159 (00673978462950), 2019101446 (20643169086702), 2019101446 (00673978462950), 2019111051 (20643169086702), 2019111051 (00673978462950), 2019120418 (20643169086702), 2019120418 (00673978462950), 2020010051 (20643169086702), 2020010051 (00673978462950), 2020010446 (20643169086702), 2020010446 (00673978462950), 2020020094 (20643169086702), 2020020094 (00673978462950), 2020020764 (20643169086702), 2020020764 (00673978462950), 2020021113 (20643169086702), 2020021113 (00673978462950), 2020040403 (20643169086702), 2020040403 (00673978462950), 2020041125 (20643169086702), 2020041125 (00673978462950), 2020041431 (20643169086702), 2020041431 (00673978462950), 2020050353 (20643169086702), 2020050353 (00673978462950), 2020050919 (20643169086702), 2020050919 (00673978462950), 2020060370 (20643169086702), 2020060370 (00673978462950), 2020060673 (20643169086702), 2020060673 (00673978462950), 2020070374 (20643169086702), 2020070374 (00673978462950), 2020080075 (20643169086702), 2020080075 (00673978462950), 2020120620 (20643169086702), 2020120620 (00673978462950), 2021010035 (20643169086702), 2021010035 (00673978462950), 201906C177 (20643169086702), 201906C177 (00673978462950), 2017090238 (00673978462950), 2018080450 (20643169086702), 2018080451 (20643169086702), 2018090065 (20643169086702), 2018091021 (20643169086702), 2018100523 (20643169086702), 2018100524 (20643169086702), 2018120893 (20643169086702), 2019010457 (20643169086702), 2019010765 (20643169086702), 2019011214 (20643169086702), 2019020007 (20643169086702), 2019030064 (20643169086702), 2019030065 (20643169086702), 2019030721 (20643169086702), 2019031169 (20643169086702), 2019040844 (20643169086702), 2019040845 (20643169086702), 2019040846 (20643169086702), 2019041191 (20643169086702), 2019050167 (20643169086702), 2019050577 (20643169086702), 2019050846 (20643169086702), 2019051127 (20643169086702), 2019060219 (20643169086702), 2019060220 (20643169086702), 2019060687 (20643169086702), 2019060985 (20643169086702), 2019060986 (20643169086702), 2019070613 (20643169086702), 2019071115 (20643169086702), 2019081002 (20643169086702), 2019090072 (20643169086702), 2019090393 (20643169086702), 2019091025 (20643169086702), 2019100418 (20643169086702), 2019101095 (20643169086702), 2019110084 (20643169086702), 2019111050 (20643169086702), 2019120927 (20643169086702), 2020010052 (20643169086702), 2020011621 (20643169086702), 2020020472 (20643169086702), 2020030065 (20643169086702), 2020050354 (20643169086702), 2020050700 (20643169086702), 2020060067 (20643169086702), 2020060068 (20643169086702), 2020060964 (20643169086702), 2020060965 (20643169086702), 2020070055 (20643169086702), 2020070655 (20643169086702), 2020070969 (20643169086702), 2020071273 (20643169086702), 2020081034 (20643169086702), 2020090632 (20643169086702), 2020110762 (20643169086702), 2020120079 (20643169086702), 2020120621 (20643169086702), 2021010553 (20643169086702), 2021011168 (20643169086702), 2021011169 (20643169086702), 2021011170 (20643169086702), 2021031116 (20643169086702), 2021031308 (20643169086702), 2021031309 (20643169086702), 2021040093 (20643169086702), 2021040871 (20643169086702), 2021041149 (20643169086702), 2021050635 (20643169086702), 201901C051 (20643169086702), 201903C128 (20643169086702), 201905C013 (20643169086702), 201906C176 (20643169086702), 202011C198 (20643169086702), 202106C012 (20643169086702), 202106C013 (20643169086702), 202106C014 (20643169086702), 202106C020 (20643169086702), 202106C021 (20643169086702). Expiration date range: 09/30/2020 - 05/19/2024 | 48,672 units |
What to do — step by step
Check Product Details
Review the model number and lot numbers listed in the recall notice to confirm if your device is affected.
Contact Medtronic
Reach out to Medtronic directly for further instructions on how to return or replace the device.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 34 states.
FDA distribution: “Nationwide distribution to AL, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI. International distribution to Albania, Algeria, Australia, Austria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.
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.
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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-2505-2021 (August 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2505-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.