Ares Antibiotic-Impregnated Catheter

• 3 recalls, same reason

  • Ongoing Z-0738-2021 FDA Class II ·initiated 8 Dec 2020
  • Ongoing Z-0740-2021 FDA Class II ·initiated 8 Dec 2020
  • Ongoing Z-0739-2021 FDA Class II ·initiated 8 Dec 2020

  There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

Full name

Medtronic Ares Antibiotic-Impregnated Catheter

510(k) Number

K110560 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• StrataMR II Valves and Shunts

  Class II

  FDA 510(k) K212641 Active Cleared 16 Sep 2021

• Medtronic Ps Medical Strata Type Value Open recall

  Class II

  FDA 510(k) K060681 Active Cleared 15 Sep 2006

• Rivulet Ventricular and Snap Shunt and Convertible Ventricular Catheters, Models 41701 and 41704-41715

  Class II

  FDA 510(k) K063836 Active Cleared 16 Aug 2007

• U-Clip Device

  Class II

  FDA 510(k) K062821 Active Cleared 19 Dec 2006

• Medtronic Strata Nsc Lumboperitoneal Valve and Shunt System Open recall

  Class II

  FDA 510(k) K123524 Active Cleared 13 Feb 2013

• Ps Medical Strata II Valve Open recall

  Class II

  FDA 510(k) K042465 Active Cleared 19 Oct 2004

See all devices from Medtronic Neurosurgery →

• What is the primary purpose of the Medtronic Ares Antibiotic-Impregnated Catheter?

  The Ares Antibiotic-Impregnated Catheter is specifically designed to reduce the risk of infection in hydrocephalus management by incorporating antibiotic-impregnated materials. It is part of a ventricular shunt system, facilitating cerebrospinal fluid (CSF) drainage from the brain’s ventricular system to another drainage site while minimizing microbial colonization during long-term implantation.

• How is the Ares Catheter supplied and what are its sterility and usage guidelines?

  The Ares Catheter is supplied as a single-use, sterile device, adhering to standard sterile medical device protocols. It is intended for one-time use only and must be handled under aseptic conditions to maintain sterility. Since it is designed for long-term implantation with tissue/bone contact, proper sterile techniques are critical to prevent contamination during and after implantation.

• Is the Ares Catheter compatible with other Medtronic shunt systems, and how do I select the correct reference code?

  Yes, the Ares Catheter is designed for seamless integration with Medtronic shunt valves and systems, ensuring no size mismatches. To select the correct reference code, refer to the specific model required for your patient’s procedure. The device is available in multiple reference codes (e.g., 3014334038, 3016577622), so consult your Medtronic representative or product documentation to confirm compatibility with your chosen shunt system.

• What storage and handling instructions apply to the Ares Antibiotic-Impregnated Catheter?

  The Ares Catheter should be stored following standard sterile medical device protocols. This includes keeping it in its original packaging until immediately before use, protecting it from physical damage, and ensuring it remains in a clean, dry environment. Avoid exposure to extreme temperatures or moisture. Since it is single-use, do not reuse or restock the device after opening.

• Does the Ares Catheter have any MRI safety restrictions?

  The provided device data does not mention any specific MRI safety restrictions for the Ares Antibiotic-Impregnated Catheter. However, it is always recommended to verify MRI compatibility with the manufacturer’s guidelines or product documentation before use in an MRI environment, as safety can depend on specific clinical scenarios and imaging protocols.