Protection system

Cardiovascular Systems, Inc. (NASDAQ: CSII) – Cardiovascular Systems recalls Wirion Embolic Protection System

Cardiovascular Systems Inc (NASDAQ: CSII) has launched a voluntary recall of its WIRION (WIRION) Embolic Protection Systems.

  • Unused WRN-D6 models of the WIRION device are being recalled due to received complaints of a filter rupture at the time of recovery.
  • The Company said the rupture of the filter could cause embolism of the device as well as further intervention.
  • All affected health facilities have been advised to stop using and return unused WIRION devices to the Company.
  • CSI has also notified the FDA regarding the voluntary recall.
  • The company has so far received nine complaints of broken filters and plans to recall all devices currently in stock with customers.
  • Between March 22 and November 15, approximately 697 devices were distributed in the United States.
  • WIRION is a rapid exchange, preloaded filter used as an embolic protection system to remove embolic material (thrombus / debris) when performing atherectomy in calcified lesions of the lower limbs.
  • In March, CSI acquired a portfolio of peripheral support catheters from WavePoint Medical.
  • These catheters are used during Peripheral Vascular Intervention (PVI) procedures for guidewire support to facilitate crossing of lesions and for guidewire exchanges.
  • CSI plans to introduce the catheters acquired as a new ViperCross line in the first half of its fiscal year, ending June 30, 2022.
  • Price action: CSII shares closed at $ 23.72 on Wednesday.