Device recall: Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatm

FDA enforcement event 78570 · Class II · initiated 3 Nov 2017 · status Terminated · terminated 1 Sep 2020

DeviceVoluntary: Firm initiated1 product recordPlymouth, MN

Medtronic Inc. (Plymouth, MN) initiated this device recall on 3 Nov 2017; FDA lists 1 product record under event 78570, 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 1 Sep 2020. Initiation: voluntary: firm initiated. Medtronic Inc. has 47 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

Medtronic Inc., Plymouth, MN.

Reason for recall

"Stent length on the label may not match the length of the stent itself."

Distribution

"Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0188-2018	Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from…	21 units	Class II	Terminated	6 Dec 2017

Context

93%of 2017 device events are Class II1,091 events that year

1product record in this eventfirm median: 1

47events on this register for the firm

Other enforcement events for Medtronic Inc.

Initiated	Product (first record)	Type	Class	Records
11 Mar 2026	Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial f	Device	Class II	1
4 Dec 2025	Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090	Device	Class II	1
29 Oct 2025	Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product	Device	Class II	1
18 Jun 2025	Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Cro	Device	Class II	2
17 Jun 2025	Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software compo	Device	Class II	2
29 Apr 2025	Azure S DR MRI SureScan, Product number W3DR01	Device	Class II	1
11 Jul 2024	2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE	Device	Class II	1
16 Apr 2024	COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator	Device	Class II	23
16 Feb 2024	Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090	Device	Class II	1
7 Dec 2023	Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1	Device	Class II	1

All 47 events for Medtronic Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Stent length on the label may not match the length of the stent itself."

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: "Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 1 Sep 2020. "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.