Medtronic Inc.: Medical Device Recall in 2015 - (Recall #: Z-0200-2016)

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:

Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.

Product Classification:

Class II

Date Initiated: September 29, 2015

Date Posted: November 11, 2015

Recall Number: Z-0200-2016

Event ID: 72115

Reason for Recall:

64 units of Achieve Electrical Cables were shipped with a potential sterility breach.

Status: Terminated

Product Quantity: 64 units

Code Information:

Lot U531

Distribution Pattern:

Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated