Terumo Cardiovascular Systems Corp Cardiovascular Procedure Kit catalog # 76645 & 73806 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cardiovascular Procedure Kit catalog # 76645 & 73806
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
[Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]
Products Sold
[Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]
Terumo Cardiovascular Systems Corp is recalling Cardiovascular Procedure Kit catalog # 76645 & 73806 due to Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
Recommended Action
Per FDA guidance
A customer notification letter was issued on 02/23/2022 by 2-day FedEx mailing advising customers to remove the affected product from use and return to Terumo CVS using the instructions provided.
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