Case Study: Rethinking the Recall Process
With medical device recalls abounding, a new support model is simplifying the process. Learn about it here.
Category: Recalls
Recalls
Latest
Recalls
Latest
Medtronic Recalls Ventricular Assist Device Batteries
Medtronic is recalling HeartWare Ventricular Assist Device System batteries due to their ability to experience electrical faults that cause them to unexpectedly fail.
Recalls
Latest
Philips Could Be Approaching a DOJ Settlement
Philips may be looking to bring an end to its ongoing plight of medical device recalls via a settlement agreement with the DOJ.
Recalls
Latest
Case Study: Rethinking the Recall Process
With medical device recalls abounding, a new support model is simplifying the process. Learn about it here.
Dräger’s Breathing System Filter Recall Gets Class I Label from FDA After Ventilation Obstruction
Dräeger Medical, Inc. expanded on its voluntary recall of Lot LT2103 of Draeger SafeStar 55 Breathing System Filters.
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GE Healthcare’s Recall of Ventilator Batteries Gets Class I Label from FDA Over Device Shutdown Risk
Due to their ability to cause the premature shutdown of GE Healthcare’s Carescape R860 ICU ventilators, the U.S. FDA has deemed GE Healthcare’s recall of more than 100,000 batteries as a Class 1 event—the most severe kind.
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Medtronic’s HVAD Pump Implant Kit Gets Class I Recall for Weld Defect
Medtronic recalled its HeartWare Ventricular Assist Device System, which is designed to help the heart pump blood to the rest of the body.
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Abbott Recalls Imaging Catheter for Potential Loose Catheter Marker Band
The U.S. FDA has identified the Dragonfly OpStar imaging catheter as a Class I recall, the most serious type of recall.
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FDA Gets Over 21,000 Medical Device Reports, Including 124 Deaths, Linked to Philips Foam Breakdown
The FDA updated a safety communication regarding medical device reports associated with the breakdown of materials used in Philips devices.
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Medtronic’s Covidien Gets Class I Recall for Puritan Bennett 980 Ventilators
Covidien, LP is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error.
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Recalls
Latest
Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk
Medtronic is recalling its Harmony Delivery Catheter due to a risk where the bond holding the capsule at the end of the catheter may break.
