Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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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Impella RP. Product Code: 0046-0011.. Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.. Classification: Class I. Quantity: 179 units. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
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