Recall Z-0766-2019 ยท NLH Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions
BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
| Date | Dec 17, 2018 |
| Status | Terminated |
| Reason | Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP Navigation Systems. |
| Root cause | Process change control |
| Action | The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" Customer Notification Letter and attached Recall Effectiveness Check Form to Stryker Sustainability Solutions (SSS) sales representatives and international Stryker divisions to notify affected customers beginning on 12/17/2018.The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Use of the affected product(s) should be discontinued. 1) Please check your inventory for the affected devices. Affected devices may be identified through Serial Number or Expiration Date. 2) Plea |
| Quantity | 103 units |
| Distribution | US distribution to states of: GA, KS, MO FL, CA, WA, IA,; and internationally to: Germany, Japan and 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 |