Z-1471-2026Class I

Impella RP

Name: Z-1471-2026 Impella RP
Creator: Abiomed, Inc.
Published: 2026-01-27
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2026-01-27 / Open, Classified

FDA source

Abiomed, Inc. began a recall of Impella RP. Product Code: 0046-0011 on 2026-01-27. FDA classified it as Class I and gives the reason as "Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1471-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-01-27
Posted: 2026-02-27
Recalling firm: Abiomed, Inc.
Product: Impella RP. Product Code: 0046-0011.
Product code: PYX Temporary Non-Roller Type Right Heart Support Blood Pump
Reason for recall: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 179 units
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Product codes and lots: Product Code: 0046-0011. UDI-DI: 04260113630273. Distributed outside the US.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1471-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1469-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-02-27
Z-1470-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-02-27
Z-1471-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-02-27

Product code PYX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)