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HeartMate II and 3 LVADs Recalled Due to Potential for Outflow Graft Obstruction

Initiated by Abbott/Thoratec and deemed Class I by the FDA, the recall is a response to reports of 273 injuries and 14 deaths.

Drug-administration
Abbott-thoratec-corporation
Thoratec-corporation
Urgent-medical-device-correction-letter

Reports of Injuries, Deaths Prompt FDA to Recall Heart Failure Devices

One study showed the blockages occurred in about 3% of patients with the devices, with the likelihood of obstructions rising over time.

Michigan
United-states
Francis-pagani
Abbott-laboratories
Drug-administration
University-of-michigan
Health-news
Thoratec-corp
Pagani
Healthday-news
Urgent-medical-device-correction-letter
Cardiovascular-surgery

Reports of Injuries, Deaths Prompt FDA to Recall Heart Failure Devices

Hundreds of injuries and 14 deaths have been linked to the devices

Michigan
United-states
Francis-pagani
Pagani
University-of-michigan
Drug-administration
Thoratec-corp
Abbott-laboratories
Health-news
Healthday-news
Urgent-medical-device-correction-letter
Cardiovascular-surgery

IRADIMED CORPORATION Issues Urgent Medical Device Correction

IRADIMED CORPORATION Issues Urgent Medical Device Correction
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John-glenn
Iradimed-corporation
Wall-street
Urgent-medical-device-correction-letter
Adapter-sets
Adapter-set
Magnetic-resonance-imaging
Minimum-alveolar-concentration
John-glenn-chief-financial-officer

Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of a Potential Issue with Level 1® H-2 Pressure Chambers used with Level 1 Fast Fluid Flow Fluid Warmers

/PRNewswire/ Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of a potential issue with specific Level 1® H-2.

United-states
Tom-mccall
Pressure-chamber
Drug-administration
Smiths-medical
Urgent-medical-device-correction-letter
Flow-fluid
Flow-fluid-warmers
Smith-medical
Watch-adverse-event-reporting

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