Reprocessed LASSO 2515 Nav ECO Variable Catheter (2018-12-16)
- Starting date:
- December 16, 2018
- Posting date:
- January 9, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-68668
Affected products
Reprocessed LASSO 2515 Nav ECO Variable Catheter
Reason
Stryker received a report of failure mode. A trend was identified by manufacturer indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO EP Navigation Systems. There have been no injuries reported as a result of this event.
Affected products
Reprocessed LASSO 2515 Nav ECO Variable Catheter
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- D134301
Companies
- Manufacturer
-
Stryker Sustainability Solutions, Inc.
1810 West Drake Dr.
Tempe
85283
Arizona
UNITED STATES