Recall Z-1471-2026 ยท PYX Temporary Non-Roller Type Right Heart Support Blood Pump
Abiomed, Inc.
Impella RP. Product Code: 0046-0011.
| Date | Feb 27, 2026 (initiated Jan 27, 2026) |
| Status | Open, Classified |
| 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 Instructi |
| Quantity | 179 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.