Abiomed recalled 179 Impella RP devices worldwide after a differential pressure sensor may drift. The fault can cause sensor values to drift, potentially affecting patient care. Stop using the device immediately and follow the recall instructions, including contacting Abiomed or your healthcare provider.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
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The Impella RP is a percutaneous right ventricular assist device used to temporarily support the heart’s right ventricle in patients with certain heart conditions.
A malfunctioning differential pressure sensor can produce drift in readings, potentially affecting clinical decisions and patient safety.
This recall is not described as part of a broader industry pattern in the provided notice.
Hospitals must halt use of the affected devices and follow recall procedures. There could be patient care disruptions while devices are removed or replaced.
UDI label on device packaging and the packaging insert; product labeling.
Remedy timeline not specified in the notice. Follow manufacturer instructions and the recall letter; consult the FDA page for updates.
Keep the recall notice, product code, UDI, and any correspondence with the manufacturer. Document device serial numbers and disposition actions.
Model numbers: Product Code 0046-0011; UDI-DI 04260113630273. Where sold: Hospitals and healthcare facilities worldwide, including US nationwide and listed countries. When sold: Unknown. Price: Unknown.
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