Medtronic—MindFrame Capture LP Devices: May Partially Detach or Separate from Delivery Wire

March 7, 2018 | Risk Management News

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​​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org​.

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...

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