Safety Alert: Class I: The catheters may not retain their shape.
healthClass IRecalled on Sep 10, 2025
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
🔢 41200 units
Sold At: Medtronic Perfusion Systems(Worldwide - US Nationwide distribution.)
Recall #: FDA-DEVICE-Z-2481-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- 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
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Summary
The catheters may not retain their shape.
What to do next
- 1URGENT: Stop using this product immediately - serious health hazard
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Medtronic Perfusion Systems for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.