FDAApril 14, 2017device
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 2017. The 7-10014 pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. To date, none of the associated complaints have resulted in any patient harm.
What to do
FDA enforcement status: Terminated
Brands named
cardiovascular systemscardiovascular
Recall history
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