MPO’s Most-Read Stories This Week—April 20

New and recalled products drove the bulk of MPO website traffic this past week.

Top company constants Abbott and Boston Scientific Corp. garnered unwanted attention for their recall troubles, while Avation Medical earned kudos for its FDA-cleared, wearable neuromodulation system. 

Abbott’s recall led the week in pageviews. The ranking was not surprising in light of the FDA’s Class I designation (the most serious) for the HeartMate II and HeartMate 3 left ventricular assist system (LVAS). The recall—technically a product correction, according to the FDA—was triggered by extrinsic outflow graft obstruction (EOGO), which occurs when biological material builds up between the HeartMate outflow graft and outflow graft bend relief, or additional components added during surgery. The buildup can obstruct the device, rendering it less effective in helping to pump blood. Abbott has reported 273 injuries and 14 deaths associated with the issue. 

The same designation (Class I) also landed Boston Scientific’s recall news in the top five list. The company recalled its Obsidio Conformable Embolic device after an investigation showed the product could cause bowel ischemia if delivered using the common aliquot delivery technique for embolizations for lower gastrointestinal (GI) bleeding. Using the product with the aliquot technique might prevent blood and oxygen flow to organs including the small bowel or non-target embolization. Boston Scientific advises against using the aliquot technique to deliver Obsidio Embolic for lower GI bleed embolization procedures. Eleven incidents—seven injuries and two death—have been connected to the issue.

Non-recall news of interest included Exact Sciences’ new CFO and Avation Medical’s debut of the Vivally System, a neuromodulation system for home use that delivers closed-loop, autonomously adjusted electrical stimulation to treat urge urinary incontinence (UUI) and urinary urgency caused by overactive bladder (OAB) syndrome. 

1. Abbott’s Latest HeartMate LVAD Recall Linked to 14 Deaths

2. Wearable Neuromodulation System for Urinary Incontinence Makes its Debut

3. Cross-Border Collaboration in Medical Device Development

4. Exact Sciences Appoints Aaron Bloomer as CFO

5. Boston Scientific Has a Class I Embolization Tech Recall