Impella CP sets may lose mechanical circulatory support from low purge pressure
Impella CP Sets with SmartAssist are being recalled because a low purge pressure occurrence may cause persistent alarms and, in some cases, interruption or loss of circulatory support.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Impella CP Set with SmartAssist, product codes 1000080, 1000851, 0048-0014 and 0048-0024-JP, GTIN 00813502012279, from Abiomed, Inc., is being recalled. The action covers 10 units, identified by the serial numbers in the recall notice.
The stated reason is that exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. The FDA classified the action as Class I, its most serious classification.
Distribution was within the United States, to Georgia, Iowa, Nebraska, Pennsylvania, Texas, Washington and Wisconsin, and internationally including to Czechia. The sets are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product codes, GTIN and serial numbers in the recall notice, quarantine it, and follow the instructions issued by Abiomed.
The recalled product
- Product
- Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
- Manufacturer
- Abiomed, Inc.
- Affected units
- 10
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 (10)
- GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223
- 672986
- 673252
- 644591
- 645428
- 644314
- 613525)
- 1000851 (636173)
- 0048-0014 (499250)
- 0048-0024-JP (661216).
Distribution
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
Similar recalls
- SevereAbiomed Impella RP with SmartAssist recalled as Class I
FDA (Devices) · 2026-03-11
- SevereImpella RP Heart Pump Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22
- SevereImpella 5.5 with SmartAssist Catheter Recalled for Heightened Purge Leak Rate
FDA (Devices) · 2023-05-24
- SevereImpella CP cardiac pump recalls due to motor housing interaction with stents
FDA (Devices) · 2023-07-26
- CriticalAbiomed Impella CP with SmartAssist heart pump units recalled for failed inspection
FDA (Devices) · 2024-07-24
- CriticalImpella controllers recalled over purge pressure issues from retainer failures
FDA (Devices) · 2025-10-29