Cardiovascular Systems Inc recalls
Every recall we track for Cardiovascular Systems Inc — 6 in all, from 2017–2021 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Cardiovascular Systems Inc peaked in 2021 (3); 6 since 2017.
All FDA recall records for Cardiovascular Systems Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 2 | 0 | 2 |
| 2018 | 0 | 1 | 0 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 2 | 0 | 3 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Cardiovascular Systems Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Cardiovascular Systems Inc recalls
4 shown- Use cautionMedical device
Cardiovascular Systems Inc recalls WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Cardiovascular Systems recalls WIRION Embolic Protection System (model WRN-D6) due to risk of device tearing during use, which could cause embolization. Affected units have specific lot numbers and UDI codes.
Cardiovascular SystemsNov 22, 2021 - Lower riskMedical device
Cardiovascular Systems Inc recalls DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
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.
Cardiovascular SystemsJul 21, 2021 - Use cautionMedical device
Cardiovascular Systems Inc recalls CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
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.
Cardiovascular Systems IncApr 13, 2018 - Lower riskMedical device
Cardiovascular Systems Inc recalls Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in
Cardiovascular Systems recalls Diamondback 1.5:0 Solid OAD devices due to potential labeling mix-up in two production lots. Affected units may have incorrect labeling, but no safety hazard is reported.
Cardiovascular SystemsSep 14, 2017
Cardiovascular Systems Inc recall questions
How many recalls has Cardiovascular Systems Inc had?
6 recalls from Cardiovascular Systems Inc are on record with U.S. safety agencies, from 2017–2021.
What is the most recent Cardiovascular Systems Inc recall?
Cardiovascular Systems Inc recalls WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6, dated Nov 22, 2021. Every Cardiovascular Systems Inc recall is listed on this page, newest first.
What should I do if I have a recalled Cardiovascular Systems Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Cardiovascular Systems Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.