Z-0389-2016Class II

LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the...

Name: Z-0389-2016 LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the...
Creator: LeMaitre Vascular, Inc.
Published: 2015-10-21
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2015-10-21 / Terminated / root cause: packaging

FDA source

LeMaitre Vascular, Inc. began a recall of LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi on 2015-10-21. FDA classified it as Class II and gives the reason as "Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised 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-0389-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-21
Posted: 2015-12-04
Terminated: 2019-07-12
Recalling firm: LeMaitre Vascular Inc.
Product: LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
Product code: DXE Catheter, Embolectomy
Reason for recall: Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Consignees were notified of the recall on October 21, 2015 via letter. Consignees were asked to do the following: Identify all catheters with the affected LOT and model numbers in inventory; quarantine all unused catheters from the affected LOTs and record this action in the attached form; send the form via mail, email or fax to Customer Service who will then issue an RMA-number (Return Merchandise Authorization number) for the return shipment and replacement of the products; pass this notice on to all those who need to be aware within your organization and to any organization to which the potentially affected devices have been transferred. For questions concerning this safety notice, please contact Salva Kozin, Quality Assurance Engineer, at 781-221-2266 ext. 183.
Quantity in commerce: 4315 total
Distribution: Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.
Product codes and lots: Lot Number: NSE1663

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0389-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0378-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0379-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0380-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0381-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0382-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0383-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0384-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0385-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0386-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0387-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0388-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0389-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04
Z-0390-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-04

Product code DXE

K992368Class IILemaitre Embolectomy CatheterVascutech, Inc. / cleared 1999-12-09

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)