Impella CP Pump Set Recalled for Potential Device Interaction
Abiomed is recalling the Impella CP Pump Set due to a potential device interaction with the Shockwave Coronary IVL Catheter during coronary interventions. The manufacturer will update device instructions to address this interaction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall for a potential device interaction during coronary interventions with no reported illnesses or injuries. Per the severity rubric, since the hazard is theoretical with no reported incidents, this qualifies as a risk-of-harm product where injury has not yet been reported, scoring 3 (High).
Plain-English summary
Abiomed, Inc. is recalling the Impella CP Pump Set (Product Code: 0048-0034-JP) due to a potential device interaction with the Shockwave Coronary IVL Catheter that may occur during coronary interventions. Currently, the manufacturer's labeling does not document this potential interaction.
The manufacturer will update the Instructions for Use (IFU) to include information about this device interaction. Four units were affected with serial numbers 324303, 323153, 328083, and 328085 (batch numbers 2022079852, 2022079846, 2022083745, and 2022083747). Distribution is worldwide, including the United States and numerous international markets.
The recalled product
- Product
- Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
- Manufacturer
- Abiomed, Inc.
- Hazard
- Affected units
- 4
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 (4)
- Product Code: 0048-0034-JP
- UDI-DI: 00813502011463
- Serial Numbers: 324303 323153 328083 328085
- Batch Numbers: 2022079852 2022079846 2022083745 2022083747
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
Same manufacturer · Abiomed, Inc.
See all →- HighAbiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects
FDA (Devices) · 2026-09-30
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Flag Component Failure
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22
Same hazard · device interaction
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- CriticalImpella RP Flex Devices Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22
- SevereImpella RP Heart Pump Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22
- ModerateAbiomed Impella 5.5 Recall for Potential Shockwave Catheter Interaction
FDA (Devices) · 2024-09-11
- ModerateAbiomed Recalls Impella 5.5 Sets Due to Potential Shockwave Catheter Interaction
FDA (Devices) · 2024-09-11
Similar recalls
- SevereImpella CP Blood Pump Recalled for Blade Destruction From Stent Interaction
FDA (Devices) · 2023-07-26
- SevereImpella CP cardiac pump recalls due to motor housing interaction with stents
FDA (Devices) · 2023-07-26
- SevereImpella RP Heart Pump Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22
- SevereABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22
- SevereImpella LD cardiac pump recalled for impeller damage and embolization risk
FDA (Devices) · 2023-07-26
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22