Terumo Cardiovascular Systems Corporation Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
Lots 0394979, 0400254, 0403180, 0405486, 0411500, 0414942, 0420022, 0424246, 0427742, 0430190, 0435074, 0436862, 0443077, 0452056, 0465817, 0470928, 0479748, 0484668 and 0491029.
Products Sold
Lots 0394979, 0400254, 0403180, 0405486, 0411500, 0414942, 0420022, 0424246, 0427742, 0430190, 0435074, 0436862, 0443077, 0452056, 0465817, 0470928, 0479748, 0484668 and 0491029.
Terumo Cardiovascular Systems Corporation is recalling Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovas due to A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026