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U.S. Department of Health and Human Services

Class 1 Device Recall Impella RP with SmartAssist

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 Class 1 Device Recall Impella RP with SmartAssistsee related information
Date Initiated by FirmJanuary 27, 2026
Date PostedFebruary 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1469-2026
Recall Event ID 98276
PMA NumberP170011 
Product Classification Temporary non-roller type right heart support blood pump - Product Code PYX
ProductImpella RP with SmartAssist. Product Code: 0046-0035.
Code Information Product Code: 0046-0035. UDI-DI: 00813502011869.
Recalling Firm/
Manufacturer		 Abiomed, Inc.
22 Cherry Hill Dr
Danvers MA 01923-2575
For Additional Information ContactMorgaine Johnson
612-437-5734
Manufacturer Reason
for Recall		Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
FDA Determined
Cause 2		Under Investigation by firm
ActionAbiomed 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 Commerce291 units
DistributionWorldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = PYX
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