Z-1450-2017Class II

LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52

Name: Z-1450-2017 LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
Creator: LeMaitre Vascular, Inc.
Published: 2017-02-07
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2017-02-07 / Terminated / root cause: labeling and UDI

FDA source

LeMaitre Vascular, Inc. began a recall of LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52 on 2017-02-07. FDA classified it as Class II and gives the reason as "The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1450-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-07
Posted: 2017-03-13
Terminated: 2019-09-20
Recalling firm: LeMaitre Vascular Inc.
Product: LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU) REF# e2401-52
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: LeMaitre Vascular, Inc. issued a Dear Doctor letter, on 2/7/17, to distributors and hospitals via FedEx overnight. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product requested to be returned and replaced. Questions concerning this notice contact 781-221-2266 ext. 183.
Quantity in commerce: 4673
Distribution: Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
Product codes and lots: Lot Number/Exp. Date: RST2391 2018-09 RST2394 2018-09 RST2395 2018-09 RST2406 2018-12 RST2407 2018-12 RST2414 2019-02 RST2415 2019-02 RST2421 2019-03 RST2422 2019-03 RST2429 2019-04 RST2430 2019-04 RST2435 2019-05 RST2445 2019-07 RST2446 2019-07 RST2451 2019-08

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1450-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1442-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1443-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1444-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1445-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1446-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1447-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1448-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1449-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1450-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1451-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1452-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13
Z-1453-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13

Product code DQO

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)