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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85193

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 23, 2020
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
LeMaitre Vascular, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1567-2020
Recall number
Z-1567-2020
Initiated
March 23, 2020
Classification
Class I
Status
Ongoing
Recalling firm
LeMaitre Vascular, Inc.
Quantity
43315

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.

Field note

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