Reported Sep 10, 2025 · Ongoing

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

Medtronic Perfusion Systems

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088

Is this the product you have?

  • DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Lot codes and dates
  • UDI-DI
    • 20643169880935
    • 00643169880931
    • 00681490463423
  • Serial Numbers

    86 of 86 codes

    • 2023051189
    • 2023060145
    • 2023060432
    • 2023061147
    • 2023070491
    • 2023070980
    • 2023080157
    • 2023080407
    • 2023080408
    • 2023080799
    • 2023080800
    • 2023081133
    • 2023081134
    • 2023081549
    • 2023090236
    • 2023090429
    • 2023091017
    • 2023091107
    • 2023091108
    • 2023100097
    • 2023100098
    • 2023100098
    • 2023100643
    • 2023100644
    • 2023101026
    • 2023101027
    • 2023101367
    • 2023101367
    • 2023101368
    • 2023110168
    • 2023111663
    • 2023111663
    • 2023111663
    • 2023111700
    • 2023111701
    • 2023111702
    • 2023111703
    • 2023111703
    • 2023120176
    • 2023120177
    • 2023120178
    • 2023120179
    • 2023120719
    • 2023120719
    • 2023121046
    • 2023121046
    • 2023121256
    • 2024010194
    • 2024010195
    • 2024010196
    • 2024010197
    • 2024010198
    • 2024010199
    • 2024010200
    • 2024010201
    • 2024010202
    • 2024010202
    • 2024011215
    • 2024011216
    • 2024011216
Amount recalled
25261 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

The catheters may not retain their shape.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Medtronic Perfusion Systems recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.