Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Why it was recalled
The catheters may not retain their shape.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
UDI-DI: 20643169880935, 00643169880931, 00681490463423; Serial Numbers: 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 2024011217 2024011218 2024011219 2024011219 2024011220 2024011221 2024011221 2024030367 2024030367 2024030368 2024030368 2024030841 2024030842 202307C113 202308C250 202309C023 202311C008 202311C009 202312C206 202312C207 202312C208 202401C008 202402C088 202403C101 202403C102 202406C058
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide - US Nationwide distribution.
Recall record
- Recalling firm
- Medtronic Perfusion Systems
- Product type
- Devices
- Recall number
- Z-2482-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Brooklyn Park, MN
- Recall initiated
- 2025-08-06
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2482-2025 · Source: openFDA enforcement.