Cardiovascular Systems recalls

Cardiovascular Systems has 15 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 29 Dec 2021.

Total recalls15since 2012

Last 12 months0reported

Class I320% of total

Ongoing0latest 29 Dec 2021

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 3 20%Class II 11 73%Class III 1 7%

Why cardiovascular systems is recalled

Product types

By year

2021320%
2018320%
2017427%
201617%
201517%
2014213%
201217%

All cardiovascular systems recalls, newest first

15 total

Reported	Class	Recall	Company	Reason	Where
29 Dec 2021Device	CLASS I	Wirion Embolic Protection System, Delivery Catheter recalled	Cardiovascular Systems	Other	37 states
8 Sep 2021Device	CLASS II	Stealth 360 Gen2 Peripheral Orbital Atherectomy System Micro recalled	Cardiovascular Systems	Labeling Errors	Nationwide
8 Sep 2021Device	CLASS II	Diamondback 360 Gen2 Peripheral Orbital Atherectomy System Solid recalled	Cardiovascular Systems	Labeling Errors	Nationwide
19 Sep 2018Device	CLASS II	CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump recalled	Cardiovascular Systems	Device Malfunction	Nationwide
14 Feb 2018Device	CLASS II	Peripheral Diamondback 1.25 Solid OAD recalled by Cardiovascular Systems	Cardiovascular Systems	Other	9 states
14 Feb 2018Device	CLASS II	Peripheral Diamondback 1.50 Solid OAD recalled by Cardiovascular Systems	Cardiovascular Systems	Other	9 states
31 May 2017Device	CLASS II	CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump recalled	Cardiovascular Systems	Other	44 states
3 May 2017Device	CLASS II	ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire recalled	Cardiovascular Systems	Packaging Defects	Nationwide
19 Apr 2017Device	CLASS II	ViperWire Advance Peripheral Guide Wire with Flex Tip recalled	Cardiovascular Systems	Foreign Material	Nationwide
1 Mar 2017Device	CLASS II	Diamondback 360 Peripheral 1.50 Classic recalled	Cardiovascular Systems	Other	Nationwide
6 Jul 2016Device	CLASS II	ViperWire Advance Peripheral Guide Wire, Sterilized recalled	Cardiovascular Systems	Other	Nationwide
1 Apr 2015Device	CLASS I	Diamondback 360 Coronary Orbital Atherectomy System recalled	Cardiovascular Systems	Other	Nationwide
20 Aug 2014Device	CLASS I	CSI Cardiovascular Systems, Inc. recalled	Cardiovascular Systems	Particulate Matter	Nationwide
5 Mar 2014Device	CLASS III	CSI, Diamondback 360 Coronary Orbital Atherectomy System recalled	Cardiovascular Systems	Device Malfunction	Nationwide
18 Jul 2012Device	CLASS II	CSI Stealth 360-degree Orbital Atherectomy Device (OAD) recalled	Cardiovascular Systems	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.