Recall Alerts in Implantable Cardioverter-Defibrillator Recipients: Implications for Patients and Physicians

Methods: We analyzed weekly Food and Drug Administration (FDA) Enforcement Reports issued between January 2000 and December 2008 to identify all advisories involving ICD generators and leads. We performed a retrospective analysis of all implanted patients affected by an advisory in our Cardiology department. Results: During the 8 years of the study period, 13 advisories were issued for generators and one for leads, leading to a total number of 278 of 1,051 (26.4%) device with recall alerts, divided into 196 generator failures and 82 lead failures. Premature generator replacement was performed in 11 patients, whereas nine patients underwent lead replacement. There was no major complications attributable to advisory device replacement, and minor complications occurred only in one patient (lead extraction failure). Recalls accounted for 593 extra outpatient visits with a mean number of 2.20 +/- 2.19 per patient. The total estimated cost of the device advisories in our population was 334,528 euro. Conclusions: ICD recalls and safety alerts frequently occur in ICD recipients and tend to increase in number and rate. Although potentially serious, they do not appear to be associated with substantial complications. Financial implications are important. (PACE 2011; 96-103).