Z-0559-05

LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm, Latex Model: 1601-48

Name: Z-0559-05 LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm, Latex Model: 1601-48
Creator: Lemaitre Vascular, Inc.
Published: 2005-02-07
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2005-02-07 / Terminated / root cause: packaging

FDA source

Lemaitre Vascular, Inc. began a recall of LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm, Latex Model: 1601-48 on 2005-02-07. The reason FDA records is "Product sterility maybe compromised due to defective packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0559-05
Status: Terminated
Initiated: 2005-02-07
Posted: 2005-02-24
Terminated: 2005-07-25
Recalling firm: LeMaitre Vascular Inc.
Product: LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm, Latex Model: 1601-48
Product code: DXE Catheter, Embolectomy
Reason for recall: Product sterility maybe compromised due to defective packaging
Root cause tag: packaging
FDA root cause: Other
Action: LaMaitre notified consignees by lettter advising users to check inventory and return defective product.
Quantity in commerce: 411 units
Distribution: AL, CA, FL, IN, MD, MI,NY, TN, FOREIGN: Germany
Product codes and lots: Lot numbers: SLC1202

Product code DXE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)