EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140;…

Is this the product you have?

• EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent
• The Kit MACH4 is labeled in parts"***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***"
• The Pouch MSD is labeled in parts"***EKOS***MicroSonic Device***Sterile***". EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries

Lot codes and dates

• Serial Numbers

  2,173 of 2,173 codes

  • 090220013-001
  • 090323005-001
  • 090415007-001
  • 090416010-003
  • 090421002-001
  • 090421002-003
  • 090422005-001
  • 090422005-002
  • 090422005-004
  • 090422006-001
  • 090422006-002
  • 090422006-003
  • 090422006-004
  • 090422006-005
  • 090422006-006
  • 090422007-005
  • 090423002-001
  • 090423006-001
  • 090423006-002
  • 090423007-001
  • 090423007-002
  • 090423007-003
  • 090423007-004
  • 090423007-005
  • 090423007-006
  • 090423007-007
  • 090423008-001
  • 090423008-002
  • 090423008-003
  • 090423008-004
  • 090423008-005
  • 090423008-006
  • 090423008-008
  • 090427001-001
  • 090427001-002
  • 090427001-003
  • 090427001-004
  • 090427001-005
  • 090427006-003
  • 090427006-004
  • 090427007-001
  • 090427007-002
  • 090427008-001
  • 090427008-002
  • 090427008-003
  • 090428006-001
  • 090428006-002
  • 090428007-001
  • 090428008-004
  • 090428008-005
  • 090428008-006
  • 090429004-001
  • 090429004-002
  • 090429004-003
  • 090429004-004
  • 090429004-005
  • 090429004-006
  • 090429005-002
  • 090429006-001
  • 090429006-002

  Show all 2,173 codes

Amount recalled

21,892 units

Where it was sold

• OH
• KY
• TN

Why it was recalled

EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report of MicroSonic Device (MSD) breaking during insertion or operation.

This product could cause temporary or reversible health problems — stop using it.