Impella RP Flex Devices Recalled Due to Optical Sensor Damage Risk
Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This product has received FDA Class I classification, the highest regulatory severity level for devices where there is a reasonable probability of serious adverse health consequences or death. Optical sensor damage in ventricular assist devices could result in temporary or permanent pump failure in patients who depend on the device for cardiac support.
Plain-English summary
The Impella RP Flex with SmartAssist is a heart pump device manufactured by Abiomed, Inc. A total of 2,364 units with specific serial numbers have been recalled (Product Number 1000323).
Abiomed identified a risk that optical sensors on these devices can be damaged through physical interaction with the inlet during insertion, manipulation, or removal of guidewires, central venous lines, or other devices. This damage can trigger a Placement Signal Not Reliable (PSNR) alarm and cause loss of Central Venous (CV), Pulmonary Artery (PA), and Pulmonary Artery Pulse Index (PAPi) monitoring signals. The optical sensor damage may result in temporary or permanent pump stop.
The affected units were distributed nationwide in the United States and in Canada. Healthcare providers should verify whether they have any of the recalled serial numbers in their facilities.
The recalled product
- Product
- Impella RP Flex with SmartAssist; Product Number: 1000323;
- Manufacturer
- Abiomed, Inc.
- Hazard
- optical-sensor-damage
- signal-loss
- pump-failure
- device-interaction
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)
- Product Number: 1000323
- UDI-DI: 00813502012811
- Serial Numbers: 551121
- 551122
- 551123
- 551124
- 551125
- 551127
- 551128
- 551129
- 537606
- 537610
- 537612
- 537615
- 537607
- 537608
- 537609
- 537613
- 537614
- 548547
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03