Device recall: Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation…

Class III FDA enforcement event 82319. Recall start date: 4 Mar 2019. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) started this device recall on 4 Mar 2019. The firm address in the FDA record is in Mounds View, MN. FDA put the recall in Class III. FDA event 82319 has 1 product record. The first FDA enforcement report date is 3 Apr 2019. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United…

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 82319: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1069-2019	Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD…	2917 units	Class III	Ongoing	3 Apr 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class III: 6%
Product records in this event: 1Median of the firm: 2
Events of the firm on the register: 30

Other events of the firm

Other FDA enforcement events of Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Initiated	Product (first record)	Type	Class	Records
10 May 2023	ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators	Device	Class I	120
22 Jun 2022	Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR IC	Device	Class I	6
20 Apr 2022	The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure,	Device	Class II	1
12 Apr 2022	Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA	Device	Class II	2
18 Jan 2022	LINQ II Insertable Cardiac Monitor	Device	Class II	1
19 Nov 2021	Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.	Device	Class II	1
8 Nov 2021	Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72	Device	Class II	2
12 Oct 2021	Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Cr	Device	Class II	1
9 Sep 2021	C315-HIS Delivery Catheter	Device	Class II	1
1 Jun 2021	Medtronic Reveal LINQ LNQ11 / PA96000	Device	Class II	1

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): all 30 events

Official channels

FDA enforcement report Z-1069-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 82319. https://recallregister.com/fda/iii/82319/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: International distribution in the countries of Australia, Austria, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Switzerland, United…
What quantity of product is in FDA event 82319?: The FDA record gives this quantity: 2917 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 6% of the 968 device events that started in 2019 are in Class III.