Z-0473-2019Class II

LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10

Name: Z-0473-2019 LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Creator: LeMaitre Vascular, Inc.
Published: 2018-10-01
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2018-10-01 / Terminated / root cause: packaging

FDA source

LeMaitre Vascular, Inc. began a recall of LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10 on 2018-10-01. FDA classified it as Class II and gives the reason as "Pouches from this lot are not sealed compromising the sterility". 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-0473-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-01
Posted: 2018-11-16
Terminated: 2020-04-10
Recalling firm: LeMaitre Vascular Inc.
Product: LeMaitre Vascular Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Product code: MJN Catheter, Intravascular Occluding, Temporary
Reason for recall: Pouches from this lot are not sealed compromising the sterility
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Lemaitre Vascular initiated recall by letter on October 1, 2018, provided with reason for recall action to be taken, risk to health. Complete the enclosed customer reply form, and return it to LeMaitre Vascular, Inc. Return all devices from lot PFP1055, whether they appear to be unsealed or not. If you distributed any affected product to other facilities, please forward this recall to the recipients. Contact Information: [email protected] 781-425-1671 Monday through Friday, 8:00 AM to 4:30 PM,
Quantity in commerce: 46 units
Distribution: FL Foreign: Austalia, Korea
Product codes and lots: LOT# PFP1055 Expiration Date: 2020-03-28

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0473-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0473-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-16

Product code MJN

K152833Class IIPruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc. / cleared 2016-01-21

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)