Cardiovascular Systems Recalls Orbital Atherectomy System Saline Infusion Pumps
Cardiovascular Systems Inc. is recalling 1,396 Saline Infusion Pumps that may switch to stand-by during use, requiring a reset to continue treatment.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could interrupt treatment, but the source explicitly states that no patient harm has resulted from associated complaints, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardiovascular Systems, Inc. (CSI) has initiated a recall to remove 1,396 Saline Infusion Pumps (SIP), Part Number 7-10014, Model Number SIP-3000. These devices were distributed by CSI between April 7, 2015, and April 4, 2017.
The recall is due to a defect where the pumps may switch to stand-by mode during use. This requires the pump to be reset prior to continuing treatment. To date, none of the associated complaints have resulted in any patient harm.
The affected units were distributed in the United States (including 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) and internationally in Austria, Germany, Japan, and Switzerland. Healthcare providers should check their inventory for the specific lot numbers listed in the official recall notice and contact CSI for further instructions.
The recalled product
- Product
- CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
- Manufacturer
- Cardiovascular Systems Inc
- Category
- Medical Device — Infusion Pump
- Affected units
- 1,396
Distribution
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