Ranger Percutaneous Coronary Angioplasty Catheter

• • Terminated Z-2165-2008 FDA Unclassified (pre-2012) ·initiated 1 May 2007

  The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.

• • Terminated Z-2166-2008 FDA Unclassified (pre-2012) ·initiated 1 Nov 2005

  Two lots may not be correctly labeled. Specifically , a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.

• 3 recalls, same reason

  • Terminated Z-0030-04 FDA Unclassified (pre-2012) ·initiated 20 Aug 2003
  • Terminated Z-0032-04 FDA Unclassified (pre-2012) ·initiated 20 Aug 2003
  • Terminated Z-0031-04 FDA Unclassified (pre-2012) ·initiated 20 Aug 2003

  Some of the recalled catheters have a component that has levels of pyrogens above specification.

Full name

Scimed(R) Ranger(Tm) Percutaneous Coronary Angioplasty (Ptca) Catheter

Trade Name

Scimed Ptca Dilatation Catheter

Generic Name

Catheters, transluminal coronary angioplasty, percutaneous

PMA Number

P860019 ↗

FDA Product Code

LOX

Device Class

Class II

Regulation

21 CFR Part 870.5100

Advisory Committee

Cardiovascular

FDA Decision

APRL

• Triguide Guide Catheters

  Class II

  FDA 510(k) K953515 Active Cleared 19 Sep 1995

• Scimed Viper

  Class II

  FDA 510(k) K933183 Active Cleared 9 Sep 1993

• Scimed 7Fr and 8Fr Triguide Guiding Catheters

  Class II

  FDA 510(k) K914312 Active Cleared 22 Nov 1991

• Scimed Triguide Guide Catheter

  Class II

  FDA 510(k) K944537 Active Cleared 21 Oct 1994

• Scimed Pursuit Exchange Ptca Guide Wire

  Class II

  FDA 510(k) K945159 Active Cleared 30 Dec 1994

• Scimed(R) Controlwire(Tm) Guide Wire

  Class II

  FDA 510(k) K914194 Active Cleared 9 Jun 1992

See all devices from Scimed Life Systems, Inc. →

• What is the primary purpose of the SCIMED® RANGER™ Percutaneous Coronary Angioplasty (PTCA) Catheter, and where is it used?

  The SCIMED® RANGER™ PTCA Catheter is designed specifically to dilate narrowed or obstructed coronary arteries during percutaneous coronary interventions (PCI). It is intended for use in cardiac catheterization laboratories to restore blood flow in coronary vessels, improving circulation to the heart muscle.

• Is the SCIMED® RANGER™ PTCA Catheter intended for single-use or reusable applications, and how should it be handled?

  The device is supplied sterile and explicitly intended for single-use only. Due to its sterile packaging and classification as a medical device used in invasive procedures, it must be handled according to strict sterile procedures in the catheterization lab to prevent contamination or infection.

• What regulatory pathway was followed for the approval of this catheter, and what does that mean for its use?

  The SCIMED® RANGER™ PTCA Catheter was approved through the FDA’s Premarket Approval (PMA) pathway, which is the most stringent regulatory route for high-risk medical devices. This means the device underwent rigorous clinical testing and review to ensure its safety and effectiveness before being authorized for commercial distribution. The PMA number is P860019, and it falls under product code LOX for coronary angioplasty catheters.

• Are there any specific storage requirements mentioned for the SCIMED® RANGER™ PTCA Catheter?

  While the provided data does not specify detailed storage conditions (such as temperature or humidity), the catheter is supplied sterile and must be stored in its original packaging until use. Proper storage ensures sterility and functionality, so it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until deployment in a sterile field.