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U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0117-2027%22

Class II recall Z-0117-2027: LeMaitre Vascular, Inc.

Q: How to monitor Class II recall Z-0117-2027: LeMaitre Vascular, Inc. and peer other records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow Massachusetts records like this one.

Class II recall Z-0117-2027: LeMaitre Vascular, Inc. (Massachusetts): LeMaitre Vascular, Inc. Dated 22 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0117-2027
Recalling firm	LeMaitre Vascular, Inc.
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Reason	Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Quantity	54
Distribution	US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
Recall initiated	2026-08-28
Reported	2026-10-14
Firm location	Burlington, MA, United States
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-14
Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Class II recall Z-0117-2027: LeMaitre Vascular, Inc. and 41 Massachusetts peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

Massachusetts FDAPulse records like this one: 41
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 22 days ago.

What is the FDAPulse record for Class II recall Z-0117-2027: LeMaitre Vascular, Inc. in Massachusetts?

Class II device recall Z-0117-2027 by LeMaitre Vascular, Inc.: Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components fai

How does Class II recall Z-0117-2027: LeMaitre Vascular, Inc. compare to other Massachusetts FDAPulse records?

It is 22 days old, still within a typical 45-day follow-up window.

Class II recall Z-0117-2027 vs. top 3 peers

Organization	Location	Record date
Class II recall Z-0117-2027	MA	2026-10-14
Class II recall Z-3155-2026	MA	2026-10-07
Class II recall Z-0232-2027		2026-10-28
Class II recall Z-0243-2027		2026-10-28

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