Here are seven types of problems we’ve noticed in recent medical device recalls that FDA has deemed as Class I.
1. Manufacturing Glitches
FDA announced this month that it has given Class I–status to a recall of St. Jude Medical Optisure dual coil defibrillation leads, used in defibrillators. The recall is but another reminder that manufacturing process defects can lead to grave consequences—especially for critical components such as leads for cardiac rhythm management devices.
