FDA Medical Device Recalls (openFDA)
Cardiac Assist, Inc: 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.
- Recall number
- Z-0889-2011
- 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.
- Status
- Terminated
- Initiated
- 2010-12-02
- Posted
- 2011-01-10
- Terminated
- 2011-12-01
- Reason
- Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications
- 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
- 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.
- Lot, serial or model codes
- Part number 5140-6221 - Lot numbers 2010060684 & 2010071887
- 510(k) numbers
- ["K052570"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 3002228812
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28