Fig 1.
Fig 1 shows the process of selecting recall reports as Flow Diagram in line with the PRISMA guidelines. The Flow Diagram includes two search methodologies; the link one is the process of a systematic search performed for English articles in academic databases; the right one is from data sources provided by different regulatory authorities from 193 United Nations Member States. A total of 103 recall reports have been analyzed in this study.
Table 1.
Number of cardiac implants and total recall reports.
Fig 2.
Product categories of recalled cardiac implants.
Fig 2 indicates the recall rate of six different cardiac implant categories in the 103 recall reports analyzed in this study. Of all 103 recall reports, the ratio of categories is shown: ICDs 40.8%; pacemakers 14.5%; stents 14.5%; as well as CRTs 12.7%; leads 9.7% and implantable artificial organs 7.8%.
Table 2.
Ratio of recall reasons among cardiac implant medical devices.
Table 3.
The death and serious injury reports from 103 identified recall reports.
Table 4.
Different recall management according to the same recall event in different regulatory authorities.