Renegade Hi-Flo Microcatheter

• 2 recalls, same reason

  • Terminated Z-2244-2009 FDA Unclassified (pre-2012) ·initiated 26 Aug 2009
  • Terminated Z-2245-2009 FDA Unclassified (pre-2012) ·initiated 26 Aug 2009

  Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached.

• • Terminated Z-0357-2011 FDA Unclassified (pre-2012) ·initiated 24 Aug 2009

  Sterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.

• • Terminated Z-0109-2008 FDA Unclassified (pre-2012) ·initiated 10 Sep 2007

  Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.

• • Terminated Z-0122-2007 FDA Unclassified (pre-2012) ·initiated 10 Aug 2005

  Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04

510(k) Number

K000177 ↗

FDA Product Code

KRA

FDA applicant

Boston Scientific Corp

Device Class

Class II

Regulation

21 CFR Part 870.1210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Renegade Hi-Flo Microcatheter in vascular procedures?

  The Renegade Hi-Flo Microcatheter is designed for peripheral vascular applications, specifically to facilitate coaxial tracking over a steerable guidewire. Its large inner diameter enhances flow rate, making it ideal for accessing distal and complex vascular regions where precise navigation is required.

• Is the Renegade Hi-Flo Microcatheter intended for single-use or reusable applications?

  The device is supplied as a single-use catheter, though it may be included in sterile kits in some configurations. This design ensures patient safety and reduces the risk of cross-contamination between procedures.

• What features of the Renegade Hi-Flo Microcatheter improve procedural guidance and reliability?

  The catheter features improved visibility for better procedural guidance and kink resistance to maintain integrity within tortuous vasculature. These attributes help clinicians navigate challenging vascular pathways with greater confidence.

• How many different sizes or configurations are available for the Renegade Hi-Flo Microcatheter?

  Multiple sizes and configurations are available, as indicated by the associated FEI numbers (e.g., 3012543881, 3003495548, etc.). These variations allow compatibility with a wide range of interventional procedures and patient anatomies.

• What regulatory pathway was followed for the FDA clearance of the Renegade Hi-Flo Microcatheter?

  The device underwent a traditional 510(k) clearance process through the FDA’s Cardiovascular (CV) advisory committee. It was determined to be substantially equivalent to a predicate device, as reflected in the decision code (SESE) and the classification under 21 CFR 870.1210.