Cardiovascular Systems recalls STEALTH 360 GEN2 peripheral orbital atherectomy systems due to potential mislabeling of crown sizes, which could lead to incorrect use. Affected units include specific model and lot numbers.
There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
Cardiovascular Systems is recalling their STEALTH 360 GEN2 peripheral orbital atherectomy system because crown sizes might be mislabeled. This could cause incorrect use if the wrong size is used during medical procedures.
The system may have crown sizes mislabeled between 1.25mm Micro and 1.50mm Sold. Using the wrong size during a procedure could lead to incorrect treatment or complications.
Medical professionals using the STEALTH 360 GEN2 system for orbital atherectomy procedures are most at risk if they use mislabeled crown sizes. Patients receiving the procedure may be affected if the wrong size is used.
Check for the model 'STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO' and lot number 340931.
Verify the crown size on the product label to ensure it matches the intended size (1.25mm Micro or 1.50mm Sold).
The recall is for potential mislabeling of crown sizes, which could lead to incorrect use during medical procedures. However, the risk is low as the system is designed for specific procedures.
Check the product label for crown size and lot number. If mislabeled, contact Cardiovascular Systems for guidance.
Affected products have the model 'STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO' and lot number 340931.
We’ve drafted a message you can send Cardiovascular Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2386-2021 — Cardiovascular Systems Cardiovascular Systems Hello, I own a Cardiovascular Systems that is covered by recall Z-2386-2021 from Cardiovascular Systems. 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.
