Food, drugs, devices › ev3 Inc
Device recall: Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W05002
ev3 Inc (Plymouth, MN) initiated this device recall on 10 Dec 2024; FDA lists 1 product record under event 96006, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. ev3 Inc has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ev3 Inc, Plymouth, MN.
Reason for recall
"There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots."
Distribution
"Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0904-2025 | 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… | 5189 units | Class II | Ongoing | 22 Jan 2025 |
Context
Other enforcement events for ev3 Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Feb 2022 | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral va | Device | Class I | 2 |
| 6 Dec 2021 | Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommen | Device | Class I | 2 |
| 26 Aug 2020 | Pacific Xtreme (PTCA Balloon Dilation Catheter) | Device | Class II | 1 |
| 23 May 2016 | EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Pr | Device | Class II | 1 |
| 29 Mar 2016 | ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only. | Device | Class II | 1 |
| 4 Dec 2014 | ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. Indicated for the treatment of patie | Device | Class II | 2 |
| 9 Apr 2014 | ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.