UnratedMedical device recall · FDA · Published March 19, 2021
Cardiac Assist Protek Solo Venous Dilator Set Recall: Incorrect Packaging Risk
Cardiac Assist recalls 14 kits of Protek Solo Venous Dilator Set with incorrect packaging that could be distributed to patients. Affected units include specific catalog numbers and serial lots.
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.
Take action
Contact the company
📍Recalling firmCardiac Assist, Inc240 Alpha Dr · Pittsburgh, PA 15238-2906
“Cardiac Assist Protek Solo Venous Dilator Set Recall: Incorrect Packaging Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63022-cardiac-assist-protek-solo-venous-dilator-set-recall-incorrect-packaging. Based on FDA recall #Z-1486-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1486-2021%22&limit=1).
The FDA announced on March 19, 2021, that Cardiac Assist, Inc. recalled Protek Solo Venous Dilator Sets due to incorrectly packaged dilator sets in finished goods. The agency issued recall number Z-1486-2021 for the Class II device.
How to tell if you have it
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)
On Feb. 26, 2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On March 1, 2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.
Context
GovInfoNow's records show Cardiac Assist, Inc has 6 other recalls on record since Nov. 19, 2019. Other recent recalls of similar products include Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026), Diversatek Viper 3-Stage Balloon Dilator Recall (March 18, 2026), and Medline Heart Cath Pack-LF Kits Recall (March 24, 2026).
How to tell if you have this one
Check for catalog numbers 5840-2417, 5840-2415, 5740-2417, or 5100-1422 with specific serial lots listed in the UDI codes. The kits were distributed starting in February 2021.
Brand
Cardiac Assist
Product
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the catalog number and serial lots listed in the UDI codes to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, AZ, IL, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Illinois, Tennessee.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1486-2021 (March 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1486-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.