FDA recall Z-2482-2025
Medtronic Perfusion Systems · Class I · device
Product
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Reason for recall
The catheters may not retain their shape.
Distribution
Worldwide - US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-08-06
- Report date
- 2025-09-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Brooklyn Park, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2482-2025