Cardiovascular Systems Inc recalls CSI Orbital Atherectomy Saline Infusion Pump (SIP-3000) due to potential switch to standby mode during use requiring reset. This device is used for atherosclerotic disease treatment in patients with peripheral or coronary artery issues.
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Cardiovascular Systems Inc recalls their Orbital Atherectomy Saline Infusion Pump (SIP-3000) because it may switch to standby mode during use, requiring reset before continuing treatment. This could interrupt critical medical procedures for patients with atherosclerotic disease in arteries.
The pump may switch to standby mode during treatment, requiring manual reset before continuing. This interruption could halt critical procedures for patients with atherosclerotic disease in their arteries. The device is designed for use in specialized medical procedures but lacks independent indicators to show when it's functioning properly.
Patients using the CSI Orbital Atherectomy Saline Infusion Pump (SIP-3000) for peripheral or coronary artery treatments are affected. Medical professionals performing procedures on these patients are most at risk.
Check for model number SIP-3000 and part number 7-10014 on the pump. This device is used for atherosclerotic disease treatment in patients with peripheral or coronary artery issues and is prescription-only.
Ensure the pump is not switching to standby mode during use by observing for the need to reset it before continuing treatment.
The pump may switch to standby mode during use, requiring reset before continuing treatment. This could interrupt critical procedures, so users should monitor for this issue.
This pump is used for patients with atherosclerotic disease in peripheral or coronary arteries who require orbital atherectomy procedures.
Look for model number SIP-3000 and part number 7-10014 on the pump. This device is prescription-only and used in specialized medical procedures.
We’ve drafted a message you can send Cardiovascular Systems Inc to request your refund or repair — edit it as you like.
Subject: Recall Z-3021-2018 — Cardiovascular Systems Inc Cardiovascular Systems Inc Hello, I own a Cardiovascular Systems Inc that is covered by recall Z-3021-2018 from Cardiovascular Systems Inc. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
