Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment.
This recall has been terminated (originally issued May 8, 2017).
- Company
- Sterilmed Inc
- Recall Initiated
- May 8, 2017
- Terminated
- May 22, 2018
- Recall Number
- Z-2669-2017
- Quantity
- 963 devices
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval.
Distribution
US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.
Lot / Code Info
all lots
Root Cause
No Marketing Application
Action Taken
Sterilmed sent an Urgent Notice Medical Device Recall letter dated April 25, 2017, to all affected customers. The letter identified affected product, stated reason for recall. Affected devices were asked to be quarantined, until returned to Stericycle, by August 31, 2017 to qualify for credit. A response form was asked to be returned. Questions can be directed to Sterilmed's Customer Care Team at 1-888-541-0078. For further questions, please call ( 877 ) 787-0369.