Z-1751-2025Class II

Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56

Name: Z-1751-2025 Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
Creator: LeMaitre Vascular, Inc.
Published: 2025-04-11
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2025-04-11 / Open, Classified / root cause: packaging

FDA source

LeMaitre Vascular, Inc. began a recall of Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56 on 2025-04-11. FDA classified it as Class II and gives the reason as "During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1751-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-11
Posted: 2025-05-12
Recalling firm: LeMaitre Vascular Inc.
Product: Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
Product code: DYG Catheter, Flow Directed
Reason for recall: During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Root cause tag: packaging
FDA root cause: Packaging process control
Action: LeMaitre notified OUS consignees beginning on 04/11/2025, and US consignees on 04/23/2025 via email and letter. Consignees were instructed to not use the devices, immediately quarantine any on hand, and complete and return the response form. Once received a LeMaitre Vascular representative will contact customers to provide return instructions. If the products were transferred or further distributed, customers were instructed to notify those customers and provide a copy of the recall letter.
Quantity in commerce: 65,977 units
Distribution: Nationwide distribution. International distribution to ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECHIA, DENMARK, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORTH MACEDONIA, NORWAY, OMAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKIYE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
Product codes and lots: UDI-DI: 00840663101535, 00840663101542. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56. Lots not expired with the following prefix: POC, QPO, XPO.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1751-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1750-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-12
Z-1751-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-12
Z-1752-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-12

Product code DYG

K811276Class IIOcclusion CatheterBionomy, Inc. / cleared 1981-06-30

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)