Perspective:

Most cardiovascular devices are designated by the U.S. FDA as Class II or Class III devices, to reflect moderate or high risk, respectively. For example, diagnostic catheters and balloon pumps are designated as Class II devices, and they are approved to enter the market via the 510(k) pathway, which requires that new devices share indications and have technological characteristics similar to those of devices that are already legally authorized for marketing. In contrast, Class III devices, such as implantable cardioverter-defibrillators and stents, are approved under the premarket approval pathway, which requires premarket clinical evidence of safety and effectiveness to obtain FDA approval, a higher burden of evidence. In the current study, the authors examined records for cardiovascular devices which after approval were designated to have Class I recalls.

Class I recalls are the FDA’s most severe designation, indicating a reasonable probability of “serious adverse health consequences or death.” The authors of the current study show that >70% of the devices which became Class I recalls had been authorized under the 510(k) pathway, the one requiring less rigorous evidence before approval. Most studies used surrogate and composite measures as primary endpoints. These findings show limited clinical evidence was used to approve the devices later found to have serious safety concerns. The authors also offer many policy prescriptions on how to improve patient safety.