Saint Paul, MN, United States
Cardiovascular Systems Inc recalls
4 recalls recorded since 2018, most recently on 22 November 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 22 November 2021
- Terminated
- 31 August 2023
- Reason
- Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.
- Distribution
- United States- AK, AL, AR, AZ, CA, DC, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS - Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0394-2022
- WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Terminated Class II Medical devices
- Recall started
- 21 July 2021
- Terminated
- 18 March 2026
- Reason
- 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.
- Distribution
- US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2385-2021, Z-2386-2021
- DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
- STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
Terminated Class II Medical devices
- Recall started
- 13 April 2018
- Terminated
- 4 November 2019
- Reason
- The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
- Distribution
- US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3021-2018
- CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and po
Terminated Class II Medical devices
- Recall started
- 14 September 2017
- Terminated
- 4 November 2019
- Reason
- Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.
- Distribution
- FL, IL, MI, MN, MO, NY, SC, TX, and WI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0506-2018, Z-0505-2018
- Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates fo
- Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates fo
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.