FDA Medical devices recall ·
DLP Left Heart Vent Catheter Malleable body and vented connector… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2482-2025
- Date
- (initiated August 6, 2025)
- Company / brand
- Medtronic Perfusion Systems
7611 Northland Dr N, Brooklyn Park, MN, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 25261 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Why was it recalled?
The catheters may not retain their shape.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide - US Nationwide distribution.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2482-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.