Abiomed recalls Impella RP with SmartAssist pumps with serial numbers listed. Optical sensors may be damaged during device insertion or manipulation, causing temporary or permanent pump stoppage.
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Abiomed is recalling specific Impella RP with SmartAssist pumps that may have optical sensors damaged by interaction with other medical devices. This could cause temporary or permanent pump stoppage during insertion, manipulation, or removal of devices.
The optical sensors in the pump can become damaged when guidewires, central venous lines, or other devices interact with the pump's inlet during insertion, manipulation, or removal. This may cause temporary or permanent pump stoppage, disrupting heart support.
Patients using the recalled Impella RP pumps for heart support are most at risk. Healthcare providers using these pumps during procedures may also be affected.
Check if your Impella RP pump has a serial number listed in the provided list (e.g., 492884, 492882, etc.). The product was sold with specific serial numbers and model numbers.
If your pump has a serial number in the list, it is affected and should be checked for optical sensor damage.
Reach out to Abiomed for guidance on next steps if your pump is affected.
The recalled model is Impella RP with SmartAssist, with specific serial numbers listed in the record.
The recall states that optical sensor damage may cause temporary or permanent pump stoppage, which could disrupt heart support. However, the record does not specify a risk of serious injury.
Check if your pump's serial number appears in the list of numbers provided in the recall record.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-0829-2025 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-0829-2025 from Abiomed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
