Device product
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.
Z-2080-2019
Product summary
- Event
- Event 82513
- Status
- Completed
- Classification
- Class II
- Quantity
- 95 units
- Official record key
device-enforcement:Z-2080-2019
Official wording
Reason: Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.
Code information: REBR1147, REBR1148, REBR1149, REBT0471, RECQ2162 and REBR1150
Distribution pattern: US Nationwide Distribution in the states of FL, CO, WI, OH, IL, KS, AZ, WV, CT, PA, AL, MI and VA
Derived failure modes
-
Unknown
Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.