Cardiovascular Systems Recalls Orbital Atherectomy Saline Infusion Pumps
Cardiovascular Systems Inc is recalling 18 Orbital Atherectomy System Saline Infusion Pumps because they 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 high-risk medical device where a functional defect (switching to stand-by) could interrupt treatment, but the source text does not report any injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Cardiovascular Systems Inc is recalling 18 units of the Orbital Atherectomy System (OAS) Saline Infusion Pump, Part Number 7-10014, Model Number SIP-3000. The affected units are distributed in Arizona, California, Florida, Georgia, Illinois, Missouri, and Texas.
The recall was initiated because the pumps may switch to stand-by mode during use. When this occurs, the pump must be reset prior to continuing treatment. The pump is a component of the OAS that provides the pumping mechanism and power to the OAD and does not have an indication independent from the system.
Healthcare providers and patients should stop using the affected pumps and contact Cardiovascular Systems Inc for further instructions. The recall covers specific lot numbers including 126925, 168143, 127026, 146337, 171566, 148400, 182537, 154011, 54512A, 62814B, 124927, and 145946.
The recalled product
- Product
- CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication…
- Manufacturer
- Cardiovascular Systems Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Lot 126925
- 168143
- 127026
- 146337
- 171566
- 148400
- 182537
- 154011
- 54512A
- 62814B
- 124927
- 145946
- and 127026
Distribution
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