PlainRecalls

ev3 Inc

Compiled from official public sources by the publisher.

11 recalls on record · Latest: Jan 22, 2025

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Agency notice ledger

Federal filing book ev3 Inc LIGHT-BOOK · SINGLE-AGENCY

#1,340 of 14,151 · 11 notices · 0.011% archive

  • BOOK 11 notices
  • RANK #1,340 of 14,151
  • SHARE 0.011% archive
  • AGENCY FDA Devices (11)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jan 22, 2025
  • PHOTO Agfa Corp.

Nearest notice-volume peer: Agfa Corp. (0 notice gap)

ev3 Inc accounts for about 0.011% of the 104,423-notice archive on 11 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where ev3 Inc sits among 14,151 recalling firms

ev3 Inc ranks 1,340th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

ev3 Inc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

11 1340th of 14151 higher than 12,735 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

ev3 Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows ev3 Inc holds about 0.011% of archive notices alongside 11 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jan 22, 2025

Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W050080090, Size: 5MM X 80MM X 90CM; 7) AB14W050080150, Size: 5MM X 80MM X 150CM; 8) AB14W050100150, Size: 5MM X 100MM X 150CM; 9) AB14W050120150, Size: 5MM X 120MM X 1
FDA Devices Critical Mar 16, 2022

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
FDA Devices Critical Mar 16, 2022

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
FDA Devices Critical Jan 26, 2022

Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid
FDA Devices Critical Jan 26, 2022

Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid,

FDA Devices Moderate Oct 7, 2020

Pacific Xtreme (PTCA Balloon Dilation Catheter)
FDA Devices Moderate Jun 29, 2016

EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at th
FDA Devices Moderate May 4, 2016

ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
FDA Devices Moderate Jan 7, 2015

ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
FDA Devices Moderate Jan 7, 2015

ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
FDA Devices Moderate Apr 30, 2014

ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter

ev3 Inc holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (11 here — thin-book).

Agfa Corp. 11 Ajinomoto Foods North America Inc. 11 Akron Pharma, Inc. 11 Amendia, Inc 11 Aniara Diagnostica LLC 11

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Agfa Corp. 11 Amendia, Inc 11 Aniara Diagnostica LLC 11 Arjohuntleigh Polska Sp. z.o.o. 11

Frequently Asked Questions

How many federal recall notices name ev3 Inc? ▼
PlainRecalls indexes 11 distinct federal recall events naming ev3 Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does ev3 Inc sit among other recalling firms? ▼
ev3 Inc ranks #1,340 of 14,151 by distinct recall-event count among 14,151 firms in this archive (90th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of ev3 Inc's notices? ▼
FDA Devices accounts for 11 of this firm's 11 indexed notices.
What product category dominates ev3 Inc's filing book? ▼
Filings for ev3 Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
ev3 Inc: 11 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming ev3 Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026