Medtronic DLP Left Heart Vent Catheters Recall: Wire Protrusion Risk

Take action

Contact the company & request your remedy

Recalling firmMedtronic Perfusion Systems7611 Northland Dr N · Brooklyn Park, MN 55428-1088

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Medtronic is recalling certain DLP Left Heart Vent Catheters due to a potential risk of wire protrusion through the catheter tip. This could lead to complications during medical procedures if the catheter is used without proper repair.

Why it’s dangerous

The catheter tip may develop a wire protrusion that could cause damage to the heart tissue during medical procedures. This risk is present when the catheter is used without a repair or replacement.

Who’s affected

Patients using the recalled catheters for heart procedures are most at risk. Healthcare providers who have these specific model/lot numbers in their inventory should also check their records.

How to tell if you have this one

Check for model numbers starting with 12116 and lot numbers listed in the detailed record. These catheters were sold between September 30, 2020, and May 19, 2024.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Recalled Catheters
Immediately stop using any recalled DLP Left Heart Vent Catheters with the specified model and lot numbers.
Contact Medtronic for Replacement
Reach out to Medtronic directly to arrange for a replacement catheter or repair.

✎ GovInfoNow

Questions people ask

Are these catheters safe to use?

The recalled catheters have a potential risk of wire protrusion through the tip, so they should not be used without a replacement or repair.

What is the expiration date range for these catheters?

The expiration date range for these catheters is from September 30, 2020, to May 19, 2024.

How can I check if my catheter is affected?

Check the model number (starting with 12116) and lot number against the list provided in the recall notice.

Take action

Contact Medtronic

We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2504-2021 — Medtronic Medtronic

Hello,

I own a Medtronic that is covered by recall Z-2504-2021 from Medtronic.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-2504-2021 (August 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2504-2021 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.

Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only

Use caution until it’s fixed