Cardiovascular Systems recalls DIAMONDBACK 360 GEN2 peripheral orbital atherectomy systems due to potential mislabeling of crown sizes, which could lead to incorrect use in medical procedures.
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 a specific model of orbital atherectomy system because crown sizes might be mislabeled. This could cause incorrect use during medical procedures if the wrong size is used.
The system may have crown sizes mislabeled between 1.50mm and 1.25mm. If a surgeon uses the wrong size during a procedure, it could lead to incorrect treatment outcomes.
Medical professionals who use this specific atherectomy system are likely affected. The risk is low as the mislabeling is a labeling error, not a safety hazard in normal use.
Check for the model name 'DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145' and lot number 340925.
Look for the model name and lot number on the product packaging or label.
No, this is a labeling error that could lead to incorrect use during procedures, but it does not pose a direct safety risk in normal use.
Check for the model name 'DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145' and lot number 340925.
The recall does not require immediate action; check the product label to confirm if it is affected.
We’ve drafted a message you can send Cardiovascular Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2385-2021 — Cardiovascular Systems Cardiovascular Systems Hello, I own a Cardiovascular Systems that is covered by recall Z-2385-2021 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.
