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BRIEF-FDA Says Bard Peripheral Vascular Issued Letter To Affected Customers On Rotarex Atherectomy Systems Usage

Reuters
2025/03/21
BRIEF-FDA Says Bard Peripheral Vascular Issued Letter To Affected Customers On Rotarex Atherectomy Systems Usage

March 20 (Reuters) - FDA:

  • FDA: AWARE BARD PERIPHERAL VASCULAR ISSUED LETTER TO AFFECTED CUSTOMERS PROVIDING UPDATED INSTRUCTIONS FOR USE FOR ROTAREX ATHERECTOMY SYSTEMS

  • FDA: IDENTIFIED BARD PERIPHERAL VASCULAR'S ATHERECTOMY CATHETER SYSTEM RECALL AS THE MOST SERIOUS TYPE

  • FDA: BD REPORTED 30 SERIOUS INJURIES, 4 DEATHS ASSOCIATED WITH ATHERECTOMY CATHETER SYSTEM ISSUE FROM BARD PERIPHERAL VASCULAR

  • FDA: BD REPORTED 115 CASES REQUIRING ADDITIONAL INTERVENTION FOLLOWING HELIX FRACTURE AND/OR BREAKAGE RELATED TO ATHERECTOMY CATHETER SYSTEM ISSUE

(((( Reuters.Briefs@thomsonreuters.com ;));))

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