FDA (Devices) recall action 82897
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Datascope Corp. is recalling CS100 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than the minimum run time of operating power.
Datascope Corp. is recalling 6,197 Cardiosave Rescue IABP units because improper battery maintenance may result in less than minimum operating power.
Datascope Corp. is recalling CS300 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than minimum run time.
Datascope Corp. is recalling 6,197 Cardiosave Hybrid Intra-Aortic Balloon Pumps worldwide due to inadequate labeling regarding battery maintenance.
Datascope Corp. is recalling CS100 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than minimum run time. Revised labeling and training are being offered.
Datascope Corp. is recalling CS300 Intra-Aortic Balloon Pumps because improper battery maintenance may result in less than the minimum required operating power.