Impella RP. Product Code: 0046-0011.

FDA device recall Z-1471-2026 · posted 2026-02-27 · Open, Classified

Recall details

Recalling firm

Abiomed, Inc.

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PYX

Quantity affected

179 units

Distribution

Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.

Date initiated

2026-01-27

Date posted

2026-02-27

Location

Danvers, MA