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.
FDA Recall Z-0889-2011 · Posted 2011-01-10
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Recalling FirmCardiac Assist, Inc
Recall StatusTerminated
Product CodeDWF
Date Initiated2010-12-02
Date Terminated2011-12-01
Product Quantity164
Reason for Recall
Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications
Firm 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.
Root Cause
Other
Distribution Pattern
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.
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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