Fenwal CATSmart Vacuum Unit Recalled for Potential Failure During Use
Fenwal Inc is recalling 198 Vacuum Units for the CATSmart system because they may stop working and display a failure message during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device failure during a procedure where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Fenwal Inc is recalling 198 Vacuum Units for the CATSmart Vacuum Pump. The CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
The recall is due to a defect where the optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use. The affected units were distributed nationwide to 24 states and Puerto Rico, as well as internationally to Canada.
Healthcare facilities and users should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service and returned to Fenwal Inc for evaluation or replacement.
The recalled product
- Product
- Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
- Manufacturer
- Fenwal Inc
- Hazard
- Affected units
- 198
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 (20)
- Material Number 9005851
- Serial Numbers: 5VTA0180
- 5VTA0183
- 5VTA0194
- 5VTA0195
- 5VTA0196
- 5VTA0197
- 5VTA0198
- 5VTA0199
- 5VTA0200
- 5VTA0201
- 5VTA0202
- 5VTA0203
- 5VTA0204
- 5VTA0205
- 5VTA0206
- 5VTA0234
- 5VTA0235
- 5VTA0236
- 5VTA0237
Distribution
Related recalls
Same manufacturer · Fenwal Inc
See all →- HighAmicus MNC Apheresis Kit at Risk of Stress Leak in Centrifuge Packs
FDA (Devices) · 2023-03-22
- HighMedical Device Apheresis Kit Recalled Due to Stress Leak Risk
FDA (Devices) · 2023-03-22
- SevereFenwal Recalls Amicus MNC Apheresis Kits Due to Centrifuge Pack Leaks
FDA (Devices) · 2021-04-14
- HighFenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks
FDA (Devices) · 2021-04-14
- HighFenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks
FDA (Devices) · 2021-04-14
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12