FDA updates on Getinge/Datascope IABP recall, labels as Class I

The FDA today updated on Getinge (PINK:GETI B) subsidiaries Datascope and Maquet’s recall of its CS100i, CSO100 and CS300 intra-aortic balloon pumps, initially announced by the company in June, labeling it as a Class I recall.

Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The recall affects approximately 9,194 units in the US with model numbers CS100i, CSO100 and CS300, including all lot numbers manufactured before June 30, 2013 and distributed between March 24, 2003 and December 11, 2013.

The recalled pumps are cardiac assist devices used to aid patients undergoing cardiac and non-cardiac surgery and to treat acute coronary syndrome and heart failure complications.

Datascope and Maquet initiated the recall due to a risk of valve failure which can prevent the balloon from inflating and deflating properly. For a patient requiring circulatory support with an IABP, a device failure or therapy stoppage without a replacement available could result in serious adverse health consequences, including death, the FDA said.

The federal watchdog said that the company implemented a design change for devices produced after June 30, 2013, but that not all devices manufactured prior to that date have been serviced and upgraded.

In June, Datascope said it received a complaint in which the device failed to initiate therapy, resulting in a patient death. The complaint involved a CS300 IABP device which failed to pump due to electrical test failure code #58, a maintenance code and an autofill failure, according to the FDA notice.

The company said the electrical test failure code was caused by a solenoid valve requiring more power than the solenoid driver board could deliver to open the valve.

To avoid the issue, the company suggested powering on the IABP prior to insertion to allow for the successful completion of of a self-test, which it says will take less than 60 seconds to perform.

Datascope recommended not leaving users unattended during IABP therapy due to the error, and said that if electrical test failure code #58 is observed, the operating physician should remove the IABP and contact Getinge.

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