Concentric Medical Inc: Medical Device Recall in 2015 - (Recall #: Z-0116-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.

Product Classification:

Class II

Date Initiated: August 19, 2015

Date Posted: October 21, 2015

Recall Number: Z-0116-2016

Event ID: 72247

Reason for Recall:

One Distal Access Catheter intended for distribution in Korea, was found at a US location.

Status: Terminated

Product Quantity: 1

Code Information:

Lot no. 37603 Expiration date: September 2016

Distribution Pattern:

US Distribution to one location in KY.

Voluntary or Mandated:

Voluntary: Firm initiated