LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • LeMaitre Over the Wire Embolectomy Catheter
  • Catalog Numbers and Lot Numbers: See full list
  • Manufacturing Dates : May 5, 2014 to July 17, 2019
  • Distribution Dates: November 7, 2014 to March 5, 2020
  • Devices Recalled in the U.S.: 49,393
  • Date Initiated by Firm: March 10, 2020

Device Use

The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the surgical removal of blood clots that are lodged in a blood vessel (emboli) and blood clots that form in the veins (thrombi). 

image of LeMaitre Over the Wire Embolectomy Catheter

Reason for Recall

LeMaitre Vascular, Inc. is recalling the Over the Wire Embolectomy Catheter due to a risk of the balloon catheter failing to deflate during use. If the balloon does not deflate, the tip of the catheter or the balloon could separate and block (obstruct) a patient’s blood vessel while the surgeon attempts to remove the inflated balloon catheter. This could cause serious health consequences including additional surgical procedures to remove the tip or balloon pieces, damage to the blood vessel, thrombosis, or death.

The FDA has received 26 Medical Device Reports, with no deaths and one (1) injury from January 1, 2018 to March 23, 2020.

Who May be Affected

Health care providers using the LeMaitre Over the Wire Embolectomy Catheter
Patients undergoing embolectomy or thrombectomy procedures with the use of these catheters

What to Do

On March 17, 2020, LeMaitre Vascular, Inc. sent customers an Urgent Medical Device Recall letter advising them of the product issue and provided the following instructions: 

  • Check your inventory and immediately quarantine any recalled devices.
  • Complete the form at the end of the letter. Please note that you must return the form even if you have no devices in inventory.
  • Scan the reply form and send it to recalls@lemaitre.com.
  • Be aware, if you have recalled devices at your facility, LeMaitre Vascular, Inc. will send you instructions for returning the devices. Once the recalled devices have been received by LeMaitre Vascular, they will arrange for replacement material.
  • If you have transferred devices to another facility, please forward a copy of the recall letter to them.

Contact Information

Customers with questions may contact Rose Lerer by email at rlerer@lemaitre.com or by phone at 781-425-1671, Monday through Friday from 8:00 AM to 4:30 PM Eastern Time.

Additional Resources:

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

Full List of Affected Devices

CATALOG # 1651-84

CATALOG #

LOT #

EXPIRATION DATE

 

CATALOG #

LOT #

EXPIRATION DATE

1651-84

OTW2847

2020-04

 

1651-84

OTW3879

2024-04

1651-84

OTW2897

2020-06

 

1651-84

OTW3892

2024-05

1651-84

OTW3273

2022-01

 

1651-84

OTW3966

2024-08

1651-84

OTW3333

2022-03

 

1651-84

OTW4009

2024-09

1651-84

OTW3379

2022-05

 

1651-84

OTW4010

2024-09

1651-84

OTW3394

2022-06

 

1651-84

OTW4017

2024-10

1651-84

OTW3418

2022-07

 

1651-84

OTW4018

2024-10

1651-84

OTW3530

2023-02

 

1651-84

OTW4024

2024-10

1651-84

OTW3543

2023-03

 

1651-84

OTW4060

2021-08

1651-84

OTW3564

2023-03

 

1651-84

OTW4063

2024-12

1651-84

OTW3620

2023-05

 

1651-84

OTW4064

2024-12

1651-84

OTW3700

2023-09

 

1651-84

OTW4065

2024-12

1651-84

OTW3740

2023-12

 

1651-84

OTW4117

2025-01

1651-84

OTW3758

2023-12

 

1651-84

OTW4201

2025-05

1651-84

OTW3805

2024-02

 

1651-84

OTW4238

2025-07

1651-84

OTW3865

2024-04

 

1651-84

OTW4239

2025-07

CATALOG # 1651-88

CATALOG #

LOT #

EXPIRATION DATE

 

CATALOG #

LOT #

EXPIRATION DATE

1651-88

OTW2957

2020-10

 

1651-88

OTW3981

2024-09

1651-88

OTW3001

2020-12

 

1651-88

OTW3982

2024-09

1651-88

OTW3190

2021-09

 

1651-88

OTW4011

2024-09

1651-88

OTW3266

2021-12

 

1651-88

OTW4025

2024-10

1651-88

OTW3267

2021-12

 

1651-88

OTW4026

2024-10

1651-88

OTW3395

2022-06

 

1651-88

OTW4030

2024-10

1651-88

OTW3400

2022-07

 

1651-88

OTW4031

2024-10

1651-88

OTW3424

2022-08

 

1651-88

OTW4052

2024-11

1651-88

OTW3531

2023-02

 

1651-88

OTW4053

2024-11

1651-88

OTW3565

2023-03

 

1651-88

OTW4054

2024-11

1651-88

OTW3637

2023-07

 

1651-88

OTW4066

2024-12

1651-88

OTW3638

2023-07

 

1651-88

OTW4067

2024-12

1651-88

OTW3658

2023-07

 

1651-88

OTW4068

2024-12

1651-88

OTW3665

2023-07

 

1651-88

OTW4073

2024-12

1651-88

OTW3670

2023-08

 

1651-88

OTW4074

2024-12

1651-88

OTW3671

2023-08

 

1651-88

OTW4075

2024-12

1651-88

OTW3682

2023-08

 

1651-88

OTW4092

2025-01

1651-88

OTW3683

2023-08

 

1651-88

OTW4093

2025-01

1651-88

OTW3694

2023-09

 

1651-88

OTW4098

2025-01

1651-88

OTW3695

2023-09

 

1651-88

OTW4099

2025-01

1651-88

OTW3701

2023-10

 

1651-88

OTW4105

2025-01

1651-88

OTW3708

2023-10

 

1651-88

OTW4106

2025-01

1651-88

OTW3727

2023-11

 

1651-88

OTW4107

2021-08

1651-88

OTW3728

2023-11

 

1651-88

OTW4119

2025-02

1651-88

OTW3747

2023-12

 

1651-88

OTW4120

2025-02

1651-88

OTW3769

2024-01

 

1651-88

OTW4157

2025-03

1651-88

OTW3770

2024-01

 

1651-88

OTW4158

2025-03

1651-88

OTW3775

2024-01

 

1651-88

OTW4188

2025-04

1651-88

OTW3776

2024-01

 

1651-88

OTW4197

2025-04

1651-88

OTW3779

2024-01

 

1651-88

OTW4220

2025-06

1651-88

OTW3780

2024-01

 

1651-88

OTW4221

2025-06

1651-88

OTW3810

2024-02

 

1651-88

OTW4222

2022-02

1651-88

OTW3820

2024-02

 

1651-88

OTW4229

2025-07

1651-88

OTW3821

2024-02

 

1651-88

OTW4230

2025-07

1651-88

OTW3853

2024-04

 

1651-88

OTW4247

2025-07

1651-88

OTW3854

2024-04

 

1651-88

OTW4249

2025-02

1651-88

OTW3860

2024-01

 

1651-88

OTW4254

2025-07

1651-88

OTW3880

2024-04

 

1651-88

OTW4255

2025-07

1651-88

OTW3881

2024-04

 

1651-88

OTW4258

2024-12

1651-88

OTW3886

2024-05

 

1651-88

OTW4259

2025-02

1651-88

OTW3893

2024-05

 

1651-88

OTW4260

2025-02

1651-88

OTW3898

2024-05

 

1651-88

OTW4261

2025-02

1651-88

OTW3899

2024-05

 

1651-88

OTW4263

2020-12

1651-88

OTW3915

2024-06

 

1651-88

OTW4291

2022-04

1651-88

OTW3916

2024-06

 

1651-88

OTW4294

2025-08

1651-88

OTW3924

2024-07

 

1651-88

OTW4339

2022-07

1651-88

OTW3930

2024-07

 

1651-88

OTW4341

2022-06

1651-88

OTW3957

2024-08

 

1651-88

OTW4363

2022-07

1651-88

OTW3958

2024-08

 

1651-88

OTW4364

2022-06

CATALOG # E1651-84

CATALOG #

LOT #

EXPIRATION

DATE

 

CATALOG #

LOT #

EXPIRATION

DATE

E1651-84

OTW2863

2020-04

 

E1651-84

OTW3862

2024-04

E1651-84

OTW2871

2020-05

 

E1651-84

OTW3863

2024-04

E1651-84

OTW2942

2020-09

 

E1651-84

OTW3882

2024-04

E1651-84

OTW2959

2020-10

 

E1651-84

OTW3896

2024-05

E1651-84

OTW2987

2020-12

 

E1651-84

OTW3897

2024-05

E1651-84

OTW3120

2021-06

 

E1651-84

OTW3907

2024-06

E1651-84

OTW3207

2021-10

 

E1651-84

OTW3908

2024-06

E1651-84

OTW3292

2022-02

 

E1651-84

OTW3931

2024-07

E1651-84

OTW3303

2022-02

 

E1651-84

OTW3936

2024-07

E1651-84

OTW3312

2022-02

 

E1651-84

OTW3944

2024-08

E1651-84

OTW3322

2022-03

 

E1651-84

OTW3945

2024-08

E1651-84

OTW3323

2022-03

 

E1651-84

OTW3962

2024-08

E1651-84

OTW3351

2022-04

 

E1651-84

OTW3963

2024-08

E1651-84

OTW3367

2022-05

 

E1651-84

OTW3978

2024-09

E1651-84

OTW3438A

2019-09

 

E1651-84

OTW3979

2024-09

E1651-84

OTW3511

2023-01

 

E1651-84

OTW3995

2024-09

E1651-84

OTW3596

2023-04

 

E1651-84

OTW3996

2024-09

E1651-84

OTW3616

2023-05

 

E1651-84

OTW4033

2024-10

E1651-84

OTW3635

2023-07

 

E1651-84

OTW4034

2024-10

E1651-84

OTW3636

2023-07

 

E1651-84

OTW4057

2024-11

E1651-84

OTW3660

2023-07

 

E1651-84

OTW4058

2024-11

E1651-84

OTW3661

2023-07

 

E1651-84

OTW4084

2024-12

E1651-84

OTW3667

2023-08

 

E1651-84

OTW4085

2024-12

E1651-84

OTW3688

2023-09

 

E1651-84

OTW4127

2025-02

E1651-84

OTW3689

2023-09

 

E1651-84

OTW4128

2025-02

E1651-84

OTW3706

2023-10

 

E1651-84

OTW4140

2025-02

E1651-84

OTW3707

2023-10

 

E1651-84

OTW4141

2025-02

E1651-84

OTW3711

2023-10

 

E1651-84

OTW4146

2025-03

E1651-84

OTW3717

2023-10

 

E1651-84

OTW4147

2025-03

E1651-84

OTW3718

2023-10

 

E1651-84

OTW4176

2025-04

E1651-84

OTW3734

2023-11

 

E1651-84

OTW4177

2025-04

E1651-84

OTW3750

2023-12

 

E1651-84

OTW4183

2025-04

E1651-84

OTW3783

2024-01

 

E1651-84

OTW4184

2025-04

E1651-84

OTW3784

2024-01

 

E1651-84

OTW4191

2025-04

E1651-84

OTW3794

2024-02

 

E1651-84

OTW4192

2025-04

E1651-84

OTW3795

2024-02

 

E1651-84

OTW4193

2025-04

E1651-84

OTW3827

2024-03

 

E1651-84

OTW4232

2025-07

E1651-84

OTW3828

2024-03

 

E1651-84

OTW4317

2025-09

E1651-84

OTW3851

2024-03

 

E1651-84

OTW4336

2025-10

E1651-84

OTW3852

2024-04

 

 

 

 

CATALOG # E1651-88

CATALOG #

LOT #

EXPIRATION DATE

 

CATALOG #

LOT #

EXPIRATION DATE

E1651-88

OTW2872

2020-05

 

E1651-88

OTW3932

2024-07

E1651-88

OTW3191

2021-09

 

E1651-88

OTW3946

2024-08

E1651-88

OTW3272

2021-12

 

E1651-88

OTW3947

2024-08

E1651-88

OTW3439

2022-09

 

E1651-88

OTW3968

2024-08

E1651-88

OTW3537

2023-02

 

E1651-88

OTW3969

2024-08

E1651-88

OTW3623

2023-05

 

E1651-88

OTW3987

2024-09

E1651-88

OTW3662

2023-07

 

E1651-88

OTW3988

2024-09

E1651-88

OTW3668

2023-08

 

E1651-88

OTW4020

2024-10

E1651-88

OTW3669

2023-08

 

E1651-88

OTW4021

2024-10

E1651-88

OTW3690

2023-09

 

E1651-88

OTW4036

2024-10

E1651-88

OTW3691

2023-09

 

E1651-88

OTW4037

2024-10

E1651-88

OTW3712

2023-10

 

E1651-88

OTW4038

2024-10

E1651-88

OTW3735

2023-11

 

E1651-88

OTW4079

2024-12

E1651-88

OTW3766

2024-01

 

E1651-88

OTW4080

2024-12

E1651-88

OTW3771

2024-01

 

E1651-88

OTW4087

2024-12

E1651-88

OTW3812

2024-02

 

E1651-88

OTW4196

2025-04

E1651-88

OTW3822

2024-02

 

E1651-88

OTW4267

2025-07

E1651-88

OTW3823

2024-02

 

Article source: http://www.fda.gov/medical-devices/medical-device-recalls/lemaitre-vascular-inc-recalls-lemaitre-over-wire-embolectomy-catheter-due-balloon-deflation-and