Medtronic—MindFrame Capture LP Devices: May Partially Detach or Separate from Delivery Wire
March 7, 2018 | Risk Management News
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In a February 26, 2018, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Medtronic states that the above devices may partially detach or separate from the delivery wire, potentially leading to vessel damage or a device foreign body obstructing the bloodstream. Medtronic also states that potential complications or irreversible injuries associated with this problem include prolonged procedure, incomplete treatment, intimal damage, vasospasm, dissection, intracranial hemorrhage, hematoma, transient ischemic attack, ischemic stroke/cerebral infarction, neurological deficit, and/or death. Medtronic further states that it has received 20 reports of partial detachment or separation related to this problem. The firm has received three reports of serious injuries and two reports of deaths potentially associated with this problem. The manufacturer has not confirmed the...