FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: Impella RP Flex with SmartAssist. Product Code: 1000323.
- Recall number
- Z-1470-2026
- Recalling firm
- Abiomed, Inc.
- Product
- Impella RP Flex with SmartAssist. Product Code: 1000323.
- Status
- Open, Classified
- Initiated
- 2026-01-27
- Posted
- 2026-02-27
- Terminated
- not on file
- Reason
- Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- 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
- 4,496 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
- Lot, serial or model codes
- Product Code: 1000323. UDI-DI: 00813502012811.
- 510(k) numbers
- not on file
- PMA numbers
- ["P170011"]
- Product code
- PYX
- Firm FEI
- 1220648
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28