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Terminated

CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

FDA Recall Z-2122-2017 · Posted None

Recalling FirmCardiovascular Systems Inc
Recall StatusTerminated
Product CodeMCX
Date Initiated2017-04-14
Date Terminated2017-10-02
Product Quantity1,396

Reason for Recall

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.

Firm Action

Consignees were sent on 4/14/2017 a CSI "Urgent Medical Device Recall" letter dated 14 APRIL 2017. The letter listed the Affected Product, Recall Description, SIP Replacement and Return & contact information. Consignees were notified the pumps will be replaced and the process is anticipated to be completed 31 August 2017. Consignees may continue to use their pumps however if a yellow light fault is observed and the troubleshooting per the IFU does not resolve the fault, discontinue use of the pump and notify CSI. Consignees were requested to complete and return the Customer Acknowledgement Form. For further information contact CSI sales Representative of Recall coordinator Jake Mellem at [email protected], 651-259-2819 - Tel.

Root Cause

Device Design

Distribution Pattern

US: AK, AL, AR, AZ. , CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, AUSTRIA, GERMANY, JAPAN, SWITZERLAND.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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