MPO’s Most-Read Stories This Week—April 15

Products new and old took center stage on MPO’s website this past week, with two major OEMs haunted by previously-released device-related problems.   

Philips Respironics added another chapter to its lingering recall nightmare by rescinding some reworked DreamStations due to incorrect or duplicate serial numbers during initial programming. The duplication can cause the therapy delivered using the incorrect prescription or factory default settings. In fact, it may fail to deliver any therapy at all and there’s no warning or indication to the user the DreamStation isn’t working the way the doctor intended or prescribed. The recall covers certain reworked DreamStations that were also recalled in June 2021. The FDA has identified Philips’ Feb. 10 recall as Class I. 

The agency also issued a Class I designation for Abbott’s Feb. 13 recall of its FreeStyle Libre Flash glucose monitoring system, FreeStyle Libre 14 day Flash glucose monitoring system, and FreeStyle Libre 2 Flash glucose monitoring system. Offering continuous glucose level monitoring, these systems help patients manage diabetes by spotting trends and tracking patterns in glucose levels so treatment can be adjusted as necessary. Abbott recalled the systems because their reader devices use rechargeable lithium-ion batteries that may get very hot, spark, or catch fire if not correctly stored, charged, or used with its Abbott-provided USB cable and power adapter. This issue doesn’t affect any of the FreeStyle Libre family of sensors.The risk of overheating, spark, or fire can occur when charging the reader with non-Abbott adapters or USB cables along with Reader and component misuse—for example, exposure to liquids, damage, and foreign material being introduced into ports.

As Philips and Abbott struggled with recall woes this week, Avation Medical and BD touted new products. Avation Medical gained FDA 510(k) clearance for its Vivally system, a non-invasive, bladder control therapy device and mobile application to treat urinary urgency and urge urinary incontinence caused by overactive bladder syndrome. Vivally doesn’t need surgery, drugs, or needle-electrodes. It is a closed-loop, non-invasive neuromodulation system that confirms activation of the tibial nerve and continuously adjusts therapy parameters for optimal output throughout the session. 

BD (Becton, Dickinson and Company), meanwhile, launched a new, easy-to-use advanced ultrasound device with a specialized probe designed to provide clinicians with optimal IV placement. The BD Prevue II System addresses an unmet need in IV access through real-time needle depth markers. The system features the BD Cue Needle Tracking System, offering a high-quality ultrasound image of the needle trajectory, and is compatible with BD Cue Needle Tracking-enabled catheters.

1. Avation Medical’s Wearable Bladder Control Therapy Earns FDA Nod

2. Philips Recalls Certain Reworded DreamStation CPAP, BiPAP Machines

3. How Analytics Can Help Medtech Manufacturers Optimize Revenue

4. BD Launches Prevue II System

5. Abbott Recalls Some FreeStyle Libre Readers Over Battery Issues