Recall Z-0200-2016
Medtronic Inc. · initiated September 29, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot U531
Reason for recall
64 units of Achieve Electrical Cables were shipped with a potential sterility breach.
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-0200-2016
- Initiated
- September 29, 2015
- Posted by FDA
- November 2, 2015
- Terminated
- March 9, 2016
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Quantity
- 64 units
- Distribution
- Distributed in DC and the states of AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, and VA.
- Recalling firm
- Medtronic Inc., Saint Paul, MN