Z-0889-2011

TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula...

Name: Z-0889-2011 TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula...
Creator: Cardiac Assist, Inc
Published: 2010-12-02
License: https://open.fda.gov/license/

Cardiac Assist, Inc / initiated 2010-12-02 / Terminated

FDA source

Cardiac Assist, Inc began a recall of TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of... on 2010-12-02. The reason FDA records is "Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0889-2011
Status: Terminated
Initiated: 2010-12-02
Posted: 2011-01-10
Terminated: 2011-12-01
Recalling firm: Cardiac Assist, Inc
Product: TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications
FDA root cause: Other
Action: CardiacAssist, Inc. sent a Voluntary Recall letter dated November 12, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to examine inventory for the affected product and remove from inventory and identify it as a recalled product by applying the enclosed "CAUTION: DO NOT USE" sticker(s) and quarantine to prevent usage. Consignees were to complete the form included with the letter and fax a copy of the form to (412) 963-9739 to coordinate the return and replacement of any affected product. For questions regarding this recall call (412) 963-7770, ext. 271.
Quantity in commerce: 164
Distribution: Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
Product codes and lots: Part number 5140-6221 - Lot numbers 2010060684 & 2010071887

Product code DWF

K052570Class IITandemheart Transseptal Cannula Set-Ef, Model 5140-6221Cardiacassist, Inc. / cleared 2006-01-17

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)