Z-1486-2021Class II

Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS...

Name: Z-1486-2021 Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS...
Creator: Cardiac Assist, Inc
Published: 2021-03-19
License: https://open.fda.gov/license/

Cardiac Assist, Inc / initiated 2021-03-19 / Terminated / root cause: packaging

FDA source

Cardiac Assist, Inc began a recall of Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 -... on 2021-03-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1486-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-19
Posted: 2021-04-23
Terminated: 2021-11-22
Recalling firm: Cardiac Assist, Inc
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)
Product code: DRE Dilator, Vessel, For Percutaneous Catheterization
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.
Root cause tag: packaging
FDA root cause: Under Investigation by 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.
Quantity in commerce: 13 kits
Distribution: US Nationwide distribution in the states of AL, AZ, IL, TN.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1486-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1486-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-05	2021-04-23

Product code DRE

K162181Class IIProtek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc. / cleared 2017-01-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)