Recall Z-0917-2018 ยท NLH Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. They are designed to obtain electrograms in the atrial re
| Date | Jan 2, 2018 |
| Status | Terminated |
| Reason | An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. |
| Root cause | Device Design |
| Action | Stryker sent an Urgent Medical Device Recall letter dated January 2, 2018, explains the reason for recall, risk to health, and instructs them to discontinue use of the affected products. The customer is to check their inventory for the affected serial numbers provided in the attachment and complete the recall effectiveness check form to indicate the amount of product in inventory. Return instructions are provided. For further questions, please call (888) 763-8803. |
| Quantity | 8 devices |
| Distribution | USA (nationwide) Distribution was made to medical facilities in AZ, CA, CT, FL, GA, IL, KS, LA, MN, MO, OH, PA, TX, VT, WA, and Wi. Foreign distribution was made to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112292 | REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER Stryker Sustainability Solutions, Oct 21, 2011 |