News | Atherectomy Devices | April 19, 2017

Cardiovascular Systems Initiates Voluntary Recall of Atherectomy Saline Infusion Pump

Company says electromagnetic interference may cause pumps to switch to standby made during use

CSI recall for saline pump on its atherectomy system

April 19, 2017 — Cardiovascular Systems Inc. (CSI) announced April 18 it had initiated a voluntary recall of its 7-10014 Saline Infusion Pump. CSI initiated a customer communication of the recall by letter and informed customers that they may continue to use the affected Saline Infusion Pumps until they receive a replacement.

The Saline Infusion Pumps provide saline and lubricant infusion during orbital atherectomy procedures and electrical power to the orbital atherectomy device. CSI has determined that electromagnetic interference present in the hospital environment may cause the pumps to switch to standby mode during use, requiring the pump to be reset prior to continuing treatment. Restoring pump operation can result in a temporary delay in the orbital atherectomy procedure. In coronary artery procedures, this delay of therapy could present an additional risk of a temporary, medically reversible injury. However, there have been no reports of patient injury to date.

The pumps included in the recall were distributed between April 7, 2015 and April 4, 2017. The company plans to recall and replace approximately 900 units currently in customer inventory. CSI expects to record approximately $1.5 million of expenses in its third quarter of fiscal 2017 related to the recall and replacement of all affected Saline Infusion Pumps. The recall and related charge do not have an adverse effect on third quarter revenue and net loss guidance provided by the company on January 25, 2017. The company will provide additional financial updates during its regularly scheduled third quarter earnings conference call on May 3, 2017.

For more information: www.csi360.com

Related Content

First U.S. Patients Treated With Second-Generation Pantheris Atherectomy Device
News | Atherectomy Devices | July 18, 2018
Avinger Inc. announced in June that several physicians have successfully treated over 40 patients for peripheral artery...
Avinger Receives FDA Clearance of Next-Generation Pantheris Device
Technology | Atherectomy Devices | May 24, 2018
Avinger Inc. announced that the company received 510(k) clearance from the U.S. Food & Drug Administration (FDA)...
Medtronic Receives FDA Clearance for Riptide Aspiration System
Technology | Atherectomy Devices | January 16, 2018
Medtronic plc announced the company’s Neurovascular business unit received U.S. Food and Drug Administration (FDA)...
Avinger Announces Treatment of First Patients With Next-Generation Pantheris
News | Atherectomy Devices | January 09, 2018
January 9, 2018 – Avinger Inc. announced that Arne Schwindt, M.D., a vascular surgeon at St.
Avinger Receives 510(k) Clearance for Pantheris Image-Guided Atherectomy Device Modifications
Technology | Atherectomy Devices | November 20, 2017
November 20, 2017 — Avinger Inc. announced in October that the company received 510(k) clearance from the U.S.
Avinger Receives CE Mark for In-Stent Restenosis Indication With Pantheris Image-Guided Atherectomy
Technology | Atherectomy Devices | September 29, 2017
Avinger Inc. recently announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the...
Ra Medical Systems Receives FDA Clearance for New Peripheral Artery Disease Treatment
Technology | Atherectomy Devices | May 30, 2017
The U.S. Food and Drug Administration (FDA) announced that it has granted market clearance to Ra Medical Systems for...
Cardiovascular Systems Inc., CSI, ECLIPSE clinical trial, Diamondback 360 Coronary Orbital Atherectomy System, first subject enrolled
News | Atherectomy Devices | April 04, 2017
Cardiovascular Systems Inc., in partnership with the Cardiovascular Research Foundation (CRF), announced the first...
CSI, LIBERTY 360 Study, ISET 2017, six-month data, lower extremity PAD
News | Atherectomy Devices | February 08, 2017
February 8, 2017 — Cardiovascular Systems (CSI) presented six-month data from its LIBERTY 360° post-market study in a
Avinger, VISION Study, two-year outcomes, LINC, Lumivascular technology, Pantheris, OCT-guided atherectomy
News | Atherectomy Devices | February 03, 2017
Avinger Inc. recently announced positive two-year clinical data from the pivotal VISION study of the company’s...
Overlay Init