w a n u Burke et al, in this issue of the Journal, estimated that he cost to Medicare related to the Medtronic Sprint Fidelis ead failures is in the range of $167,000,000 to 806,000,000. Although critics may dispute the methods sed in these calculations, the assumptions are reasonable, nd whatever the true cost may be, it is substantial. In a arger context, the cost to Medicare related to treatment of atients with medical devices that fail or cause less catatrophic problems is a huge number. A recent analysis of edical device recalls identified 113 recalls from 2005 hrough 2009 that could cause serious health problems or eath, and cardiovascular devices comprised the largest ecall category. In 2005, approximately 24,000 patients underwent procedures related to other problems with Medtronic or Guidant devices. Although the companies rovided replacements and compensated patients for up to 2,500 in out-of-pocket expenses, the remaining cost to edicare and private insurers was not shared by industry. y one estimate, the cost to Medicare related to those eplacement procedures was about $120 million. Should industry have a greater responsibility to share in the overall costs related to recalls of their devices? If industry had more liability for these costs, how would it affect their resources for research and development, support of medical education, and other services to patients, hospitals, or physicians? Would they be more cautious about introducing new technologies, and would the risk of device failures decline if industry shared a greater burden for the cost of device failures? Could this burden be counterproductive by stifling innovation at the cost of delaying the introduction of life-saving new technologies? These questions are fraught with the potential for unintended consequences. It is tempting to compare recalls of medical devices to safety recalls by the automotive industry, which can be