Concentric Medical Inc: Medical Device Recall in 2014 - (Recall #: Z-0525-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended 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 vascular systems.

Product Classification:

Class II

Date Initiated: September 26, 2013

Date Posted: December 17, 2014

Recall Number: Z-0525-2015

Event ID: 69764

Reason for Recall:

Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.

Status: Terminated

Product Quantity: 87 units

Code Information:

Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number 36050: 09-2014 Lot Number 36017: 09-2014 Lot Number 36029: 09-2014 Lot Number 35583: 02-2014

Distribution Pattern:

US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.

Voluntary or Mandated:

Voluntary: Firm initiated