Maquet Datascope Corp. is recalling the IABP due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.
FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices.
The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.
The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use.
Interruptions to the electrical connection could cause a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, loss of consciousness, or death.
The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.
Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
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