Recall Z-0467-2019 ยท NLH Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
| Date | Aug 23, 2018 |
| Status | Terminated |
| Reason | Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing. |
| Root cause | Under Investigation by firm |
| Action | On 10/30/2018 an Urgent Medical Device Recall notice was hand-delivered by a sales representative to the customer. The customer was notified that the affected devices had already been returned via the normal collections process. If affected devices were forwarded to additional facilities, the customer was asked to communicate this recall to them and to provide them with the recall effectiveness check form. Customers were asked to complete and return the recall effectiveness check form. |
| Quantity | 2 |
| Distribution | US: KS OUS: None |
| 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 |