Recall Z-0917-2018

Stryker Sustainability Solutions · initiated January 2, 2018

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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 regions of the heart. The Reprocessed 2515 NAV eco Variable EP Catheters provide location information when used with compatible CARTO EP Navigation Systems version 2.3 or higher.

Codes / lots: Serial numbers 2468846, 2468849, 2509029, 2489074, 2491174, 2500529, 2465989, and 2500528

Reason for recall

An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.

FDA-determined cause: Device Design

Action taken

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.

Details

Recall number
Z-0917-2018
Initiated
January 2, 2018
Terminated
May 2, 2018
Product code
NLH – Catheter, Recording, Electrode, Reprocessed
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.
Recalling firm
Stryker Sustainability Solutions, Tempe, AZ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0916-2018 Class IIStryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic…An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. 01/02/2018Terminated