Devices

Integra Recalls LimiTorr & MoniTorr Drainage Systems

Integra LifeSciences has recalled its LimiTorr and MoniTorr Drainage Systems due to complaints on “piece breaking off at connection point,” “broken manifold-stopcock,” “stopcock problem,” “connection where the external transducer is attached to the transducer holder bracket broke off,” and “transducer attachment on the LimiTorr/MoniTorr has cracked and was leaking.” “This breakage occurs when there is over-bending of the stopcock most often related to the use of LimiTorr or MoniTorr in combination with a Fluid Filled Transducer,” an agency notice says.

The devices are used to monitor pressure inside the skull (intracranial pressure) and to drain cerebrospinal fluid (CSF) from the brain to reduce intracranial pressure or provide temporary CSF drainage in patients with infected CSF shunts. The devices can also be used for controlled CSF drainage from the lumbar subarachnoid space, according to FDA.

Device failure could result in infection (meningitis or ventriculitis), fever, headache, over drainage leading to subdural hematoma, over-drainage leading to the shifting of brain tissue (herniation), backflow of air leading to a condition in which air or gas is trapped within the intracranial cavity (pneumocephalus), or death, the recall notice says. Serious patient injuries associated with infection and CSF leakage were reported, but no deaths have yet been reported.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome