—#139896

Product

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.

FDA product code: DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K102588
Affected lot / code info: Lot U531

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medtronic sales reps began notifying customers on 9/29/2015. Customers were told of the issue and were requested to quarantine and return un-used product. A follow-up Urgent Medical Device Recall letter was hand delivered beginning 10/6/2015. The letter again described the issue, identified affected product and asked that un-used product be returned to Medtronic. A response form was asked to be returned to Medtronic. Customer with questions can contact Medtronic AF Solutions at 888-843-8301

Recalling firm

Firm: Medtronic Inc.
Address: 8200 Coral Sea St Ne, Saint Paul, Minnesota 55112-4391

Distribution

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.

Timeline

Recall initiated: 2015-09-29
Posted by FDA: 2015-11-02
Terminated: 2016-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139896. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.