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).
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 |
|
