CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Abiomed has issued an Urgent Medical Device Correction to notify affected customers of updated use instructions for all Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices.
Affected devices:
Impella Product Code |
Impella Product Description |
Unique Device Identifier |
|---|---|---|
0046-0035 |
Impella RP with SmartAssist |
|
1000323 |
Impella RP Flex with SmartAssist |
What to Do
Monitor patient hemodynamics with an approved diagnostic device and verify Impella positioning with imaging. Clinicians should refer to the P-level flow rates listed in the Instructions for Use (as shown in the tables below) and rely on these values rather than the AIC display values.
On January 27, Abiomed sent all affected customers a letter recommending clinicians take the following actions:
- Continue to monitor patient hemodynamics with approved diagnostic devices and verify Impella positioning with imaging before clinical interventions.
- Refer to the P-level flow rates listed in the Instructions for Use (IFUs), as shown in the tables below, and rely on these values rather than the AIC display.
- The values in the IFU reflect the flow rate range of the pump on defined pressure gradients under controlled conditions.
- Clinicians should be aware that actual pump flow depends on preload, afterload, and can vary due to suction, incorrect positioning, or presence of thrombus in the inlet.
- 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. An abrupt change in flow or abrupt discrepancy from the expected flow rate listed in the IFU may indicate a need to reassess pump positioning and performance, patient conditions, and clinical hemodynamics.
- Distribute this information to appropriate personnel at your facility who manage, transport, stock, store, or use the affected product.
- If any of the affected products have been forwarded to another facility, contact that facility and provide them with this notice.
- Post a copy of this notice in a visible area for awareness.
P-Level Flow Rates
Note: Flow rate depends on preload and afterload and can vary due to suction or incorrect positioning.
Impella RP Flex with SmartAssist
| P-Level | Flow Rate (L/min) |
|---|---|
| P-0 | 0.0 |
| P-1 | 0.0-0.9 |
| P-2 | 0.0-1.3 |
| P-3 | 0.0-1.8 |
| P-4 | 0.7-2.3 |
| P-5 | 1.3-2.6 |
| P-6 | 2.0-3.0 |
| P-7 | 2.7-3.4 |
| P-8 | 3.2-3.7 |
| P-9 | 3.7-4.2 |
Impella RP with SmartAssist
| P-Level | Flow Rate (L/min) |
|---|---|
| P-0 | 0.0 |
| P-1 | 0.0-1.2 |
| P-2 | 0.0-1.6 |
| P-3 | 0.0-2.0 |
| P-4 | 1.3-2.9 |
| P-5 | 1.6-3.1 |
| P-6 | 2.4-3.5 |
| P-7 | 3.0-4.0 |
| P-8 | 3.4-4.2 |
| P-9 | 3.9-4.4 |
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Early Alert
Abiomed has identified that the differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift over time. If sensor drift occurs, the Automated Impella Controller (AIC) may display inaccurate information, including pump flow readings, Pulmonary Artery (PA) Placement Signal, Pulmonary Artery Pulsatility Index (PAPi), and Central Venous (CV) Placement Signal.
The dP sensor measures the pressure difference between the inlet and outlet of the pump and is used to calculate these displayed values. There is no way to confirm error in the flow calculation directly from the pump signals when sensor drift occurs. Inaccurate displayed information on the AIC has resulted in the user making clinical interventions including inaccurate P-level adjustments or unnecessary pump exchanges. However, the dP sensor does not affect the device’s ability to provide hemodynamic support.
As of January 15, Abiomed has reported 22 serious injuries and no deaths associated with this issue.
Device Use
The Impella RP with SmartAssist and Impella RP Flex with SmartAssist are temporary heart pumps intended to provide right heart support in patients with acute right heart failure. The device is used in hospital settings by trained health care professionals.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Abiomed, Inc. at onemed-field-actions@its.jnj.com.
Additional Company Resources
Company-provided information is posted here by the FDA as a public service.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
