Devices

Medtronic Recalls Malfunctioning StealthStation Software

Medtronic is recalling (Class 1) its StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 after customer complaints about a software error that removed numbers or letters in displayed text and replaced them by a space, in either the “distance to target” or “tip stop point” display during navigation. “The missing digit may result in the mechanical depth stop being set too short or too long and may cause the surgeon to use an incorrect measurement for placement of the biopsy tip stop during navigation,” a recall notice says.

“Performing a cranial procedure using incorrect placement could lead to serious permanent injuries, including brain, nerve, or cerebrovascular damage, abnormal functions to the brain, spine, or muscles, paralysis, or death,” the notice says. To date, Medtronic reports 28 complaints related to the issue, which include no reported injuries or deaths.

The StealthStation is intended as an aid for locating anatomical structures during neurosurgery (treatment of diseases or disorders of the brain and spine), according to the company. It is indicated for use in any medical condition where stereotactic surgery of the brain or spine may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified in relation to images of the anatomy, it adds.

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