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# Datascope Field Correction of Intra-Aortic Pumps
- URL: https://www.fdaweb.com/datascope-field-correction-of-intra-aortic-pumps/
- Published: 2017-06-19T12:00:00.000Z
- Updated: 2026-09-14T22:30:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138968

Datascope Corp. has begun a field correction involving certain Intra-Aortic Balloon Pumps due to a potential electrical test failure code. This action also applies to any System 98 or System 98XT pump that was converted to a CS100i or CS300 pump. The company says it received a complaint that has been associated with a patient death because of the device’s failure to initiate therapy due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. “An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve,” an [FDA notice](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwNjE5Ljc0Nzg1NDgxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDYxOS43NDc4NTQ4MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDI0OTQ3JmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&102&&&https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563615.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says. There are about 12,000 affected units sold globally.