LeMaitre Vascular, Inc. LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.
Brand
LeMaitre Vascular, Inc.
Lot Codes / Batch Numbers
Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099
Products Sold
Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099
LeMaitre Vascular, Inc. is recalling LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended t due to The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Recommended Action
Per FDA guidance
On 04/01/2021, LeMaitre issued an Urgent Medical Device Removal notice via letter informing customers that particulate contamination has been detected from the packaging foam with these devices.
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