DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Summary
The FDA issued a Class I for DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 by Medtronic Perfusion Systems. Reason: The catheters may not retain their shape..
Details
Source
Device Recall
External ID
Z-2481-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Lot/Code Info: UDI-DI: 20643169880676, 00643169880672, 00673978176468, 00763000946432, 20763000946436; Serial Numbers: 2023120708 2023120708 2023120709 2023120710 2023120711 2023120712 2023121041 2023121041 2023121042 2024011203 2024011203 2024011204 2024020135 2024020136 2024020137 2024020138 2024020138 2024020139 2024020140 2024020141 2024020141 2024020471 2024020472 2024020473 2024020474 2024020474 2024020474 2024020475 2024020475 2024020475 2024020806 2024020806 2024020806 2024030359 2024030360 2024030360 2024030361 2024030361 2024030361 2024030833 2024030833 2024030834 2024030834 2024030835 2024030835 2024031088 2024031088 2024050074 2024050075 2024050076 2024050403 2024050404 2024050761 2024050762 2024050763 2024050763 2024051075 2024051076 2024051265 2024060283 2024060284 2024060284 2024060285 2024060529 2024070340 2024070340 2024071120 2024071120 2024071121 2024071121 2024071122 2024071122 2024080225 2024080225 2024080465 2024080465 2024080690 2024081023 2024081024 2024090228 2024090229 2024090470 2024090470 2024090471 2024090767 2024090768 2024100621 2024100622 202312C204 202312C205 202401C295 202401C296 202403C144 202403C145 202403C146 202405C079 202405C080 202406C064 202406C065 202406C066 202409C128
Quantity Affected: 41200 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-2481-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29