Recall archive / FDA device enforcement
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110 — FDA record Z-2481-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 6, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
- Reason
- The catheters may not retain their shape.
- Classification
- Class I
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 41200 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2481-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 10, 2025
- Recall initiation date
- Aug 6, 2025
- Center classification date
- Sep 3, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.