Heart pump sets recalled after being packaged in the wrong outer carton
Abiomed is recalling 6 Impella 5.5 with SmartAssist S2 sets because the device was packaged in an incorrect outer box carton.
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 2/5 (Moderate).
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: Scored 2 because the record cites an incorrect outer carton with no stated consequence or reported harm.
Plain-English summary
The Impella 5.5 with SmartAssist S2 and the Impella 5.5 with SmartAssist S2 Set, AU, are being recalled by Abiomed, Inc.
The reason given in the enforcement record is that the device was packaged in an incorrect outer box carton.
The record lists 6 units, catalog number 1000482 with Australian configuration code 1000770 and GTIN 00813502012828, including serial number 621454. Distribution was international, to Australia and Taiwan. The FDA has classified the action as Class II.
The record describes a packaging error and states no consequence or reported injuries. Facilities should follow Abiomed's instructions.
The recalled product
- Product
- Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Heart pump
- Affected units
- 6
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 (8)
- Catalog Number: 1000482
- Australian Configuration Code: 1000770
- GTIN: 00813502012828
- Serial No. 621454 & 621455
- Exp. Date 6/30/27. *** UPDATE 05/02/2026*** Serial numbers added: 621448
- 621449
- 621450
- and 621451
Distribution
Distribution scope not specified by the agency.
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 · packaging error
See all →- ModerateTerumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging
FDA (Devices) · 2026-08-19
- LowRio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
FDA (Devices) · 2026-07-22
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- ModerateArtegraft vascular graft recalled over incorrect lot outer packaging labeling
FDA (Devices) · 2026-03-25
- ModerateBD syringe batch may contain Luer Slip instead of Luer Lok
FDA (Devices) · 2026-03-18
Similar recalls
- ModerateImpella 5.5 Cardiac Pump Recalled for Undocumented Device Interaction
FDA (Devices) · 2024-09-11
- SevereAbiomed Impella 5.5 pump recalled due to impeller blade damage risk
FDA (Devices) · 2023-07-26
- SevereAbiomed Impella 5.5 SmartAssist S2 heart pump introducer sheath leakage risk
FDA (Devices) · 2026-07-22
- HighImpella 5.5 Device Recalled for Missing Labeling on Catheter Interaction
FDA (Devices) · 2024-09-11
- CriticalAbiomed Impella CP with SmartAssist heart pump units recalled for failed inspection
FDA (Devices) · 2024-07-24
- SevereImpella RP Heart Pump Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22