San Diego, CA (PRWEB) June 05, 2014
AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for HeartMate II LVAS Pocket System Controller.
The FDA announced on April 1, that the previous recall of HeartMate II LVAS Pocket System Controller, by Thoratec Corporation, was classified as Class I as patients did not receive intensive training on connecting the new controller. Due to the design differences between the EPC System Controller and the Pocket System Controller the device is connected differently and without proper connection. the device cannot function.
Four deaths and five reports of loss of consciousness or other symptoms of hypoperfusion have been reported. The vast majority of the events occurred in patients who were converted to the Pocket Controller after being originally trained on the older model EPC System Controller.
The affected devices are:
HeartMate II Implant Kit with Pocket Controller: Catalog Numbers 106015 and 106016
Pocket Controller: Catalog Numbers 106762 and 106017
HeartMate II LVAD Pump and Pocket Controller Kit: Catalog Number 107801
Pocket Controllers that have been removed from packaging: Model Number 105109 (found on side of each unit)
Taking into consideration the latest developments, AttorneyOne.com monitor daily and update the website providing accurate information on all relevant FDA safety alerts. Sean Burke, director of Media Relations at AttorneyOne.com, adds “we are determined to keep an eye on FDA announcements concerning HeartMate II LVAS Pocket System Controller) and inform the public. For that reason", he continues, "our focus should squarely fall on investigating these safety alerts and getting the word out.”
The US FDA advises “Consumers who have the HeartMate II LVAS Pocket Controller should immediately contact their doctor for retraining on use of the device and to receive updated Patient Handbook information.” And the Agency adds “Physicians who prescribe the HeartMate II LVAS Pocket Controller should immediately review the updated labeling and training materials provided in the Urgent Medical Device Correction Letter with all clinical personnel responsible for training patients and caregivers on the use of the Pocket System Controller.”
AttorneyOne.com has further information on HeartMate II LVAS Pocket System Controller at the website including latest major drug and medical products law news.
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