Abiomed Issues with the Impella Heart Pump Device
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May 5, 2026 -
KBD Attorneys - No Comments
Abiomed Issues with the Impella Heart Pump Device
Abiomed has had continuous issues with the Impella heart pump device. Perhaps most significantly, the Impella device can puncture, or poke a hole through, the wall of the heart. This is a serious complication that can lead to a severe bleed in the heart, which can be fatal.
FDA has highlighted the issue several times in its communications with Abiomed. First, FDA issued a warning letter in September 2023 that, in part, addressed the fact that Abiomed was trying to correct the issue by sending non-FDA approved messages to healthcare professionals. The letter can be found here:
Instructions for Use (IFU)
Ultimately, FDA and Abiomed recalled what are called the Instructions for Use, or IFU, for the Impella device because of the perforation issue. The IFU is a very detailed instruction manual for using the Impella device. It is over 200 pages long. The IFU is critical to patient safety because it also carries warnings and other precautionary statements that can alert doctors to safety issues with the Impella. Critically, the Impella IFU does not warn doctors that the Impella device can perforate the wall of the heart.
Technical Bulletin
Abiomed issued a “Technical Bulletin” in October 2021 about the perforation issue, but it did not remove the product from the market or otherwise warn doctors of the life-threatening complication. You can find a link to the October 2021 Technical Bulletin here: https://www.heartrecovery.com/
Why is Ventricular Perforation a Concern?
Perforation can cause:
- Free Wall Rupture: A severe and often fatal condition where the heart wall completely breaks.
- Hypertension: Dangerous spikes in blood pressure.
- Reduced Blood Flow: Inability to maintain circulation to vital organs.
- Death: 49 deaths have been linked to this issue as of the latest FDA reports.
Actions and Recommendations
In December 2023, Abiomed issued new warnings and recommendations for the use of Impella pumps, including:
- Careful Positioning: Ensuring the pump catheter is positioned accurately to prevent damage to the heart wall.
- Imaging Guidance: Using imaging tools during procedures to monitor the device’s placement and avoid errors.
- Special Precautions: Taking extra care with high-risk patients, such as the elderly or those with heart disease.
Why is This a Problem?
If the fluid leaks, the system can lose the pressure it needs to work correctly, which can trigger alarms and require medical staff to evaluate and fix the problem. If the leakage isn’t resolved:
- The pump might stop working.
- This could leave the patient without the heart support they need.
- For critically ill patients, this failure can make their condition worse or even lead to serious injuries or death.
Perforation
Add a paragraph about perforation here. Include an AI image if you can find one, that looks like the Impella perforating the heart wall.
Talk about how serious it can be, how it is fixed (surgery), and whether there is a prolonged recovery/diminished heart function after.
End with the same KBD is investigating the Impella Device section and invite them to contact us for a free consultation.
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