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)
FDA Recall Z-1486-2021 · Posted None
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Recalling FirmCardiac Assist, Inc
Recall StatusTerminated
Product CodeDRE
Date Initiated2021-03-19
Date Terminated2021-11-22
Product Quantity13 kits
Reason for Recall
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.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of AL, AZ, IL, TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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