Z-1567-2020Class I

LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The...

Name: Z-1567-2020 LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The...
Creator: LeMaitre Vascular, Inc.
Published: 2020-03-23
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2020-03-23 / Open, Classified / root cause: manufacturing process

FDA source

LeMaitre Vascular, Inc. began a recall of LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is... on 2020-03-23. FDA classified it as Class I and gives the reason as "There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1567-2020
Classification: Class I
Status: Open, Classified
Initiated: 2020-03-23
Posted: 2020-04-01
Recalling firm: LeMaitre Vascular Inc.
Product: LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
Product code: DXE Catheter, Embolectomy
Reason for recall: There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On March 23, 2020, the firm distributed "URGENT: MEDICAL DEVICE RECALL" letters to affected customers. Customers were notified of the risk of the catheter failing to deflate, which may ultimately lead to tip separation. Customers were asked to do the following: 1. Check your inventory and immediately quarantine any recalled devices. 2. Complete the form at the end of this letter. Please note that you must return the form even if you have no devices in inventory. 3. Scan the reply form and send it to [email protected]. 4. If you have recalled devices at your facility, LeMaitre Vascular, Inc. will send you instructions for returning the devices. 5. When the recalled devices have been received by LeMaitre Vascular, we will arrange for replacement material. 6. If you have transferred devices to another facility, please forward a copy of this recall letter to them. Customers with questions may contact the Senior Quality Engineer, at [email protected] or 781-221-2266. ***Updated 8/21/20*** Firm added Lots OTW4180, OTW4187, OTW4198, OTW4202, OTW4218, OTW4246 to the recall. These lots were previously on hold in a warehouse in Germany, but in July they were mistakenly distributed to customers in Europe.
Quantity in commerce: 43315
Distribution: Worldwide distribution: US (Nationwide distribution) and foreign countries of: Australia, Austria, Belgium, Bulgaria, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Georgia, Hungary, Ireland, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam.
Product codes and lots: OTW2897¿ OTW3273¿ OTW3333¿ OTW3379¿ OTW3418¿ OTW3543¿ OTW3564¿ OTW3620¿ OTW3700¿ OTW3740¿ OTW3758¿ OTW3805¿ OTW3865¿ OTW3879¿ OTW3892¿ OTW3966¿ OTW4009¿ OTW4010¿ OTW4017¿ OTW4018¿ OTW4024¿ OTW4060¿ OTW4063¿ OTW4064¿ OTW4065¿ OTW4117¿ OTW4201¿ OTW4238¿ OTW4239¿ OTW2957¿ OTW3001¿ OTW3266¿ OTW3395¿ OTW3565¿ OTW3637¿ OTW3638¿ OTW3658¿ OTW3665¿ OTW3670¿ OTW3671¿ OTW3682¿ OTW3683¿ OTW3694¿ OTW3695¿ OTW3701¿ OTW3708¿ OTW3727¿ OTW3728¿ OTW3747¿ OTW3769¿ OTW3770¿ OTW3775¿ OTW3776¿ OTW3779¿ OTW3780¿ OTW3810¿ OTW3820¿ OTW3821¿ OTW3853¿ OTW3854¿ OTW3880¿ OTW3881¿ OTW3886¿ OTW3893¿ OTW3898¿ OTW3899¿ OTW3915¿ OTW3916¿ OTW3924¿ OTW3930¿ OTW3957¿ OTW3958¿ OTW3981¿ OTW3982¿ OTW4011¿ OTW4025¿ OTW4026¿ OTW4030¿ OTW4031¿ OTW4052¿ OTW4053¿ OTW4054¿ OTW4066¿ OTW4067¿ OTW4068¿ OTW4073¿ OTW4074¿ OTW4075¿ OTW4092¿ OTW4093¿ OTW4098¿ OTW4099¿ OTW4105¿ OTW4106¿ OTW4107¿ OTW4119¿ OTW4120¿ OTW4157¿ OTW4158¿ OTW4188¿ OTW4197¿ OTW4220¿ OTW4221¿ OTW4222¿ OTW4229¿ OTW4230¿ OTW4247¿ OTW4249¿ OTW4254¿ OTW4255¿ OTW4258¿ OTW4259¿ OTW4260¿ OTW4261¿ OTW4263¿ OTW4291¿ OTW4294¿ OTW4339¿ OTW4341¿ OTW4363¿ OTW4364¿ OTW2942¿ OTW2959¿ OTW2987¿ OTW3207¿ OTW3292¿ OTW3303¿ OTW3312¿ OTW3322¿ OTW3323¿ OTW3351¿ OTW3367¿ OTW3438A¿ OTW3511¿ OTW3635¿ OTW3636¿ OTW3660¿ OTW3661¿ OTW3667¿ OTW3688¿ OTW3689¿ OTW3706¿ OTW3707¿ OTW3711¿ OTW3717¿ OTW3718¿ OTW3734¿ OTW3750¿ OTW3783¿ OTW3784¿ OTW3794¿ OTW3795¿ OTW3827¿ OTW3828¿ OTW3851¿ OTW3852¿ OTW3862¿ OTW3863¿ OTW3882¿ OTW3896¿ OTW3897¿ OTW3907¿ OTW3908¿ OTW3931¿ OTW3936¿ OTW3944¿ OTW3945¿ OTW3962¿ OTW3963¿ OTW3978¿ OTW3979¿ OTW3995¿ OTW3996¿ OTW4033¿ OTW4034¿ OTW4057¿ OTW4058¿ OTW4084¿ OTW4085¿ OTW4127¿ OTW4128¿ OTW4140¿ OTW4141¿ OTW4146¿ OTW4147¿ OTW4176¿ OTW4177¿ OTW4183¿ OTW4184¿ OTW4191¿ OTW4192¿ OTW4193¿ OTW4232¿ OTW4317¿ OTW4336¿ OTW2872¿ OTW3191¿ OTW3439¿ OTW3537¿ OTW3623¿ OTW3662¿ OTW3668¿ OTW3669¿ OTW3690¿ OTW3691¿ OTW3712¿ OTW3735¿ OTW3766¿ OTW3771¿ OTW3812¿ OTW3822¿ OTW3823¿ OTW3836¿ OTW3849¿ OTW3850¿ OTW3874¿ OTW3888¿ OTW3903¿ OTW3925¿ OTW3932¿ OTW3946¿ OTW3947¿ OTW3968¿ OTW3969¿ OTW3987¿ OTW3988¿ OTW4020¿ OTW4021¿ OTW4036¿ OTW4037¿ OTW4038¿ OTW4079¿ OTW4080¿ OTW4087¿ OTW4196¿ OTW4267¿ OTW4268¿ OTW4269¿ OTW4270¿ OTW4275¿ OTW4276¿ OTW4277¿ OTW4288¿ ***Added 3/19/20*** OTW2847¿ OTW2863¿ OTW2871¿ ***Updated 4/14/20*** The firm noted upon review that some of the original recall lots were originally relabeled with different lot numbers for Non-US customers. Those additional lot numbers are as follow: OTW3461 OTW3501 OTW3591 OTW3628 OTW3737 OTW3742 OTW3753 OTW3813 OTW3859 OTW3861 OTW4208 ***Updated 8/21/20*** Lots OTW4180, OTW4187, OTW4198, OTW4202, OTW4218, OTW4246

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1567-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1567-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-04-08	2020-04-01

Product code DXE

K022145Class IIOver the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. / cleared 2003-01-14

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)