Cardiovascular Systems Inc
Complete recall history across all FDA and CPSC categories — 11 total recalls
Cardiovascular Systems Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (11)
FDA medical device enforcement actions by Cardiovascular Systems Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 22, 2021 | WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval ... | Under certain circumstances, the WIRION filter assembly may become difficult ... | Class I |
| Jul 21, 2021 | STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM,... | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown O... | Class II |
| Jul 21, 2021 | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 ... | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown O... | Class II |
| Apr 13, 2018 | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Nu... | The pumps may switch to stand-by during use requiring the pump to be reset pr... | Class II |
| Sep 14, 2017 | Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy sys... | Cardiovascular Systems, Inc. (CSI) is removing the products because it was id... | Class II |
| Sep 14, 2017 | Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy sys... | Cardiovascular Systems, Inc. (CSI) is removing the products because it was id... | Class II |
| Apr 14, 2017 | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Nu... | Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7... | Class II |
| Mar 3, 2017 | ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18.... | Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with F... | Class II |
| Feb 9, 2017 | ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number... | CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHE... | Class II |
| Dec 7, 2016 | DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Or... | CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. | Class II |
| Jun 13, 2016 | ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx O... | The pouch label was missing the use by date (UBD) of 2018-04. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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