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Impella Heart Pump recallZ-1470-2026 · Abiomed, Inc. · initiated Jan 27, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abiomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

FDA root cause category: Under Investigation by firm

What the company is doing

Abiomed notified consignees on about 01/27/2026 via UPS delivery. Additionally, the Customer Letter was posted on Heartrecovery.com: https://www.heartrecovery.com/en-us/resources/downloads/field-safety-notification-impella-rp-differential-pressure-sensor. The notifications informed consignees were instructed clinicians that affected units can continue use and they should: 1. Continue to monitor patient hemodynamics with approved diagnostic devices and continue to verify Impella positioning with imaging before clinical interventions. 2. Refer to the P-level flow rates listed in the Instructions for Use (IFUs), as shown in Figure 1, and rely on these values rather than the AIC display. 3. Trend pump metrics to monitor pump performance and to identify sudden change, noting that abrupt changes in the displayed flow rate need to be assessed both against the flow rate listed in the IFU and across temporal trends. Consignees were instructed that product is NOT being removed from the field and does not need to be returned, patients should be assessed with approved diagnostic devices before clinical interventions, complete and return the provided business reply form (BRF) to Abiomed4437@sedgwick, forward the notification to anyone in the facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products) and if any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.

Recall details

Recall number
Z-1470-2026
Status
Open, Classified
Initiated by the company
Jan 27, 2026
Posted by the FDA
Feb 27, 2026
Recalling firm
Abiomed, Inc.
Quantity
4,496 units
Product code
PYX
FDA submissions
P170011
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.

Product description

Impella RP Flex with SmartAssist. Product Code: 1000323.

Code information (models, lots, serial numbers)

Product Code: 1000323. UDI-DI: 00813502012811.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

6 devices cleared under P170011 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98276).

Sources and updates

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