CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump
Medical device recall Z-2122-2017. Published in FDA’s Enforcement Report on May 31, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 31, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 44 states named in where it went
- 1,396 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
1,396, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Number 92254 92693 106281 106282 106283 106284 106285 106286 106287 106288 106290 106543 118121 118223 121782 123165 123489 123547 123808 123878 124088 124289 124925 124927 124989 125310 125347 125362 126696 126797 126925 127026 127155…
Every code shown here, 1,999 characters
Lot Number 92254 92693 106281 106282 106283 106284 106285 106286 106287 106288 106290 106543 118121 118223 121782 123165 123489 123547 123808 123878 124088 124289 124925 124927 124989 125310 125347 125362 126696 126797 126925 127026 127155 127221 127348 127614 127742 127834 128001 128027 128132 128179 128326 129266 129303 132418 132839 132966 133231 133429 133759 133880 134057 134318 134534 134966 135199 135372 135791 135941 136729 136881 136883 137221 137361 137657 137862 138218 138462 138614 139049 139295 139621 140470 140606 142474 142596 142604 142909 143084 143213 143277 143335 143419 143553 143556 143806 144066 144276 144496 145536 145946 146051 146199 146337 146401 146518 146843 146999 147508 147530 148129 148169 148400 148712 148897 149117 149268 149527 150273 150285 150774 150831 151196 151228 151440 151635 151867 151994 152092 152178 152321 152389 152522 152889 153280 153678 154011 154434 154682 154948 155270 156044 156340 156683 156713 157869 158004 152178 152321 158124 158234 158370 158422 158558 158617 160312 160352 160995 161165 161241 161328 161466 161603 161679 161774 161892 162318 162344 162384 162402 162421 162439 163493 163600 164048 164293 164561 164873 165087 165353 165811 165971 166068 166226 166653 166863 166907 167024 167115 167146 168006 168048 168052 168087 168093 168143 168173 168589 169662 170066 170315 170350 170385 171566 171679 171915 172145 172379 172490 172491 172755 172859 172871 173226 173486 173783 174051 174434 174621 174637 174659 175087 175167 176653 177218 177359 177385 177625 178212 178237 178742 179133 179287 179558 179602 179649 179955 180225 180360 180463 180629 181317 181320 181556 181586 182441 182442 182494 182495 182537 182539 183099 183101 183150 183400 186393 186683 186820 186881 187241 187242 187398 101182a 101534A 102274a 103369a 104183B 105371a 106346A 106346b 108335A 110016A 111785a 111785b 114148a 114964a 49267-4A 50805A 50805a 50891A 50949A 50949B 51191A 51344A 51345A 51498A 51498B 51570A 51571a 51725A 52006A…
FDA’s list runs to 3,181 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
44 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 14, 2017.
- FDA classified it on May 20, 2017.
- FDA’s Enforcement Report published it on May 31, 2017.
- FDA terminated it on Oct 2, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cardiovascular Systems Inc, of Saint Paul, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,181 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.