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
206431698809350064316988093100681490463423
- Serial Numbers
86 of 86 codes
202305118920230601452023060432202306114720230704912023070980202308015720230804072023080408202308079920230808002023081133202308113420230815492023090236202309042920230910172023091107202309110820231000972023100098202310009820231006432023100644202310102620231010272023101367202310136720231013682023110168202311166320231116632023111663202311170020231117012023111702202311170320231117032023120176202312017720231201782023120179202312071920231207192023121046202312104620231212562024010194202401019520240101962024010197202401019820240101992024010200202401020120240102022024010202202401121520240112162024011216
- UDI-DI
- 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.
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