Cardiac Assist, Inc Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)
Brand
Cardiac Assist, Inc
Lot Codes / Batch Numbers
LOT/SERIAL: 285586, 00145202, 00145204, 00871587, 00871549, 00871560, 00871561, 00871562, 00871563, 00871564, 00871565, 00871566, 00871567
Products Sold
LOT/SERIAL: 285586, 00145202, 00145204, 00871587, 00871549, 00871560, 00871561, 00871562, 00871563, 00871564, 00871565, 00871566, 00871567, UDI: (01) 00814112020463(17)231024(11)201024(10)285586 (01)00814112020517(17)220222(11)210118(21)00145202 (01)00814112020517(17)220222(11)210118(21)00145204 (01)00814112020708(17)210203(11)220117(21)00871587 (01)00814112020092(17)210129(11)220117(21)00871549 (01)00814112020092(17)210129(11)220117(21)00871560 (01)00814112020092(17)210129(11)220117(21)00871561 (01)00814112020092(17)210129(11)220117(21)00871562 (01)00814112020092(17)210129(11)220117(21)00871563 (01)00814112020092(17)210129(11)220117(21)00871564 (01)00814112020092(17)210129(11)220117(21)00871565 (01)00814112020092(17)210129(11)220117(21)00871566 (01)00814112020092(17)210129(11)220117(21)00871567
Cardiac Assist, Inc is recalling Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840- due to On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.
Recommended Action
Per FDA guidance
On 3/11/2021 LivaNova issued an Urgent Medical Device Correction notice via letter notifying customers the firm identified an error with the assembly of a limited number of ProtekSolo Venous Dilator Sets. The ProtekSolo Venous Dilator Set 14-22 Fr should contain 3 dilators: 14Fr, 18Fr and 22Fr. A limited number of boxes labeled as ProtekSolo Venous Dilator Set 14-22 Fr incorrectly contain 4 dilators: 14Fr, 18Fr, 22Fr and 26Fr.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026