![]() ![]() Medical Device Recall Database entry: Impella 5.5 with SmartAssist Intravascular Micro Axial Blood Pump.Medical Device Recall Database entry: Impella LD Intravascular Micro Axial Blood Pump.Medical Device Recall Database entry: Impella CP with SmartAssist Intravascular Micro Axial Blood Pump. ![]() Medical Device Recall Database entry: Impella 2.5 Intravascular Micro Axial Blood Pump 005042.Medical Device Recall Database entry: Impella CP Intravascular Micro Axial Blood Pump.Medical Device Recall Database entry: Impella 5.0 Intravascular Micro Axial Blood Pump.Post a copy of the notice in a visible area for awareness.Ĭustomers with questions about this recall should contact Shashi Thoutam at +1(734) 262-6255 and/or their local clinical field staff.If any of the subject products have been forwarded to another facility, contact that facility and provide them with the notice.Forward the notice to anyone in the facility who needs to be informed, including people who manage, transport, store, stock, or use the subject products.Review, complete all fields, sign, and return the business response form to the recall coordinator identified in the notice.Note that product is NOT being removed from the field and does not need to be returned.Replace the Impella pump as soon as possible.Consider damage of the impeller as a possible cause.If there is low flow observed in a patient implanted with a TAVR while on Impella heart pump support:.Turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity to the valve stent structures.Avoid repositioning while the device is spinning.Position the Impella system carefully in patients with TAVR. ![]() Be aware of this potential interaction between the Impella system and TAVR.The notice included the following recommended actions: Actions for clinicians On June 14, 2023, Abiomed sent an Urgent Medical Device Correction notice to customers. Health care personnel providing care for people who receive support using the Impella Left Sided Blood Pumps.People who receive ventricle and circulatory support from Impella Left Sided Blood Pumps.Please note that clinicians may continue to use the devices, with the additional instructions for patients with TAVR in mind. Use of affected devices may cause serious injury or death.Ībiomed reports 30 complaints, 26 injuries, and four deaths related to this issue. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream. This could be life threatening in people who require high levels of support. The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. ![]() The contact may damage or destroy the motor’s impeller blades. There is a potential risk that the Impella motor housing may come into contact with the distal stent of a transcatheter aortic valve replacement (TAVR). The IFU lacks guidance to clinicians on how to manage use of Impella in patients with TAVR and fails to describe how the issue may present if an Impella interacts with TAVR. Reason for RecallĪbiomed is recalling the Impella Left Sided Blood Pumps because the pumps’ Instructions for Use (IFU) do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR). Impella therapy aims to reduce the work of the heart’s ventricles and provide support for the circulatory system so the heart has time to recover. Impella Left Sided Blood Pumps also are used when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack (acute myocardial infarction), open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy. Impella Left Sided Blood Pumps are used for short term support of the pumping chambers of the heart (ventricles) during high-risk catheter-based procedures called percutaneous coronary interventions (PCI).
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