CSI — Class II medical device recall Z-2122-2017
Terminated recall by Cardiovascular Systems Inc, reported 2017-05-31, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP)
| Recall number | Z-2122-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiovascular Systems Inc, Saint Paul, MN, United States |
| Recall initiated | 2017-04-14 |
| Classified | 2017-05-20 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2017-10-02 |
| Distributed | 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 |
| Countries outside the US | AT, CH, DE, JP |
| Quantity | 1,396 |
| Lot numbers | 101182A, 101534A, 102274A, 103369A, 104183B, 105371A, 106281, 106282, 106283, 106284, 106285, 106286, 106287, 106288, 106290, 106346A, 106346B, 106543, 108335A, 110016A, 111785A, 111785B, 114148A, 114964A, 118121, 118223, 121782, 123165, 123489, 123547, 123808, 123878, 124088, 124289, 124925, 124927, 124989, 125310, 125347, 125362 and 408 more |
| Model numbers | 7-10014, SIP-3000 |
Product
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2122-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.