Terumo Sarns cardiovascular disposable products, Weighted… recallZ-2046-2009 · Terumo Cardiovascular Systems Corporation · initiated Feb 5, 2008
Terminated All recalls posted in August 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.
FDA root cause category: Process control
What the company is doing
Consignees were notified via Urgent - Medical Device Removal letters dated 2/5/08 to cease use of the product. Terumo CVS will contact customers to arrange replacement for the affected product upon receipt of the attached response form. Questions are to be directed to Terumo CVS Customer Service at 1-800-521-2818.
Recall details
- Recall number
- Z-2046-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 5, 2008
- Posted by the FDA
- Aug 4, 2009
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 7079
- Product code
- DTS
- FDA submissions
- K982891
- Distribution
- Worldwide Distribution --- including USA and countries of Belgium, Brazil, Dominican Republic, Germany, Jordan and Latin America.
Product description
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
Code information (models, lots, serial numbers)
Lots 0394979, 0400254, 0403180, 0405486, 0411500, 0414942, 0420022, 0424246, 0427742, 0430190, 0435074, 0436862, 0443077, 0452056, 0465817, 0470928, 0479748, 0484668 and 0491029.
Other devices under the same FDA submission
4 devices cleared under K982891 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS9 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS6 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS2 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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