Recall of Wingman35 Crossing Catheters

Medical Device Safety

Yesterday, the FDA issued a safety alert warning of ReFlow Medical’s 4/22/17 lot-specific voluntary recall of its Wingman35 Crossing Catheters distributed between January 2015 and March 2016. According to the FDA, the Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. Tip splitting has the…

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Shoulder Replacement Recalled for Higher Fracture Rate – Could This Be Yours?

Shoulder Replacement Recall

Today the FDA reported that Zimmer Biomet is recalling its Comprehensive Reverse Shoulder System Humeral Tray Model 115340 because “these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely,…

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Physio-Control Warns Defective LIFEPAK 1000 Defibrillators Can Shut Down During Resuscitation Attempts

Recalls

On January 13, 2017, Physio-Control, a provider of professional emergency medical response solutions, announced a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment.  The company admits that it has received 34 reports where customers have attempted to use their LIFEPAK 1000…

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