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Medtronic is relaunching its Harmony Transcatheter Pulmonary Valve (TPV) system after a March 2022 recall following six reports of a failure of the capsule at the end of the delivery catheter.
At the end of the surgery, the surgeon removes the device with the needles stored safely inside, eliminating the potential for needle loss inside the patient.
Devicemakers should err on the side of caution and open a Corrective and Preventive Action (CAPA) investigation even if they are unsure it’s required, said Judith Meritz, life sciences regulatory consultant with Meritz & Muenz, in a recent WCG FDAnews webinar.
Achieving marketing authorization under FDA rules includes submitting your device under the correct classification — and companies can struggle to determine which class a new medical device falls into.
The German-based certification organization DEKRA has temporarily suspended the CE certificates for Getinge’s HLS and PLS life support sets effective March 1 due to noncompliance with the EU’s Medical Device Directive.