DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Summary
The FDA issued a Class I for DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 by Medtronic Perfusion Systems. Reason: The catheters may not retain their shape..
Details
Source
Device Recall
External ID
Z-2480-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Lot/Code Info: UDI-DI: 20643169881338, 00673978176475, 00643169881334; Serial Numbers: 2023051188 2023060142 2023060144 2023060431 2023060762 2023061146 2023061146 2023070147 2023070147 2023070148 2023070148 2023070149 2023070149 2023070150 2023070150 2023070151 2023070490 2023070490 2023070979 2023080156 2023080797 2023080798 2023080798 2023081130 2023081131 2023081131 2023081132 2023081547 2023081548 2023081548 2023090234 2023090235 2023090427 2023090675 2023090979 2023090980 2023091104 2023091105 2023091105 2023091106 2023091106 2023100243 2023100243 2023100244 2023100641 2023100641 2023100642 2023101024 2023101025 2023101025 2023101365 2023101365 2023101366 2023110247 2023110308 2023110308 2023110312 2023110312 2023121249 2023121250 2023121250 2023121251 2023121251 2023121251 2023121252 2023121253 2023121254 2023121255 2024010470 2024010471 2024010472 2024010472 2024010473 2024010474 2024010474 2024010475 2024010475 2024010476 2024010476 2024010477 2024011016 2024011016 2024011214 2024031093 2024031094 2024031095 2024040067 2024040068 2024040068 2024040069 2024040070 2024040071 2024040245 2024040245 2024060793 202307C112 202308C248 202308C249 202309C022 202310C057 202310C058 202312C203 202402C086 202403C085 202403C086 202403C087 202406C057 202407C109
Quantity Affected: 34549 units
Reason for Recall
The catheters may not retain their shape.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-06
Company
Brooklyn Park, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Perfusion Systems has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Perfusion Systems) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Perfusion Systems have FDA actions?
Medtronic Perfusion Systems has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2480-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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