FloTrac Pressure Monitoring Sensor Recalled for Setup Flushing Difficulties
Edwards Lifesciences' FloTrac Sensor with Vamp System is being recalled due to potential flushing difficulties during setup of the pressure monitoring kit. No injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall with no reported injuries, illnesses, or hospitalizations. The hazard is described as a potential operational difficulty during device setup rather than a direct reported safety threat, fitting the category of voluntary precautionary recalls.
Plain-English summary
Edwards Lifesciences, LLC is recalling the FloTrac Sensor with Vamp System, a device used for intravascular pressure monitoring in critical care settings. The recall affects 11,072 units distributed throughout the United States and multiple international countries.
The recall was issued due to potential flushing difficulties that may occur during setup of the pressure monitoring kit with pressure transducer. This is a Class II recall issued by the FDA.
Healthcare providers and facilities using these devices should identify affected units by their lot numbers and contact Edwards Lifesciences for guidance on remediation options. No injuries or illnesses have been reported in connection with this issue.
The recalled product
- Product
- FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- setup-difficulty
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- MHD6AZ: UDI:00690103194722
- Lot #: 64818047 64858313 64891437 64953982 MHD6AZ5: UDI: 00690103194746
- Lot #: 64782419 64882668 64912054 64918246 64933574 64988043 65007223 65007224
- MHD6C502: UDI: 00690103194760
- Lot #: 64951410
Distribution
Distributed in 51 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- WA
- WI
- WV
- WY
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27