Z-1529-2021Class II

LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock -

Name: Z-1529-2021 LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock -
Creator: LeMaitre Vascular, Inc.
Published: 2021-04-06
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2021-04-06 / Terminated / root cause: manufacturing process

FDA source

LeMaitre Vascular, Inc. began a recall of 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... on 2021-04-06. FDA classified it as Class II and gives the reason as "The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1529-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-06
Posted: 2021-05-04
Terminated: 2022-12-29
Recalling firm: LeMaitre Vascular Inc.
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.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 616 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.
Product codes and lots: Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1529-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1529-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-12	2021-05-04

Product code DXT

K973334Class IIOz Power SyringeCardiovascular Innovations / cleared 1998-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)