Devices

FDA Flags Recall of Erbe Flexible Cryoprobes Over Rupture Hazard

Erbe USA has recalled (Class 1) its flexible cryoprobes due to their potential to rupture during activation, which could result in severe injury or death. To date, there have been five serious injuries linked to the malfunction, FDA says.

According to Erbe USA, the issue stems from insufficient adhesive applied during manufacturing, which can lead to excessive internal pressure when the device is activated. This defect may cause the cryoprobe to rupture or burst. According to a recall notice, such failures are accompanied by a loud noise and pose multiple risks, including:

Tinnitus or temporary hearing loss
Potential permanent hearing damage
Burns or other physical injuries to patients or healthcare staff

Flexible cryoprobes are commonly used in minimally invasive procedures to destroy unwanted tissue through extreme cold (cryotherapy). They are also used for cryoadhesion applications, including the removal of mucus plugs, blood clots, foreign bodies, necrotic tissue, and for palliative tumor debulking and biopsies.

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