High FDA (Devices)·Z-0588-2018·Announced 2018-02-28

Medtronic Recalls Visia AF MRI ICDs Due to Therapy Prevention Risk

Medtronic is recalling 951 Visia AF MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (ICD) where the failure to deliver therapy could be life-threatening, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Medtronic Inc. is recalling 951 Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) from the Visia AF MRI series. The affected devices are labeled as Visia AF MRI VR SureScan ICD DF1, Visia AF MRI VR SureScan ICD DF4, Visia AF MRI S VR SureScan ICD DF1, and Visia AF MRI VR SureScan DF4. These devices are designed to automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.

The recall is due to a potential defect that may result in the prevention of high and low voltage therapy. This means the device may fail to deliver necessary electrical shocks or pacing when the patient's heart rhythm becomes dangerous. The recall covers devices distributed nationwide in the United States.

Patients with these specific device models should contact their healthcare provider or Medtronic to discuss the recall and determine the appropriate next steps for their care. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

Product: Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No.
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: therapy-prevention
device-failure
Affected units: 951

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

CWG200404H
CWG200406H
CWG200897H
CWG200898H
CWG202225H
CWG202244H
CWG202762H
CWG203250H
CWG203455H
CWG200147H
CWG200899H
CWG202761H)
b. Product No. DVFB1D4: UDI 00643169566422 (Serial No. PKX202448H
PKX205417H
PKX205779H
PKX209277H) (EXPANSION: Serial No. PKX211818H
PKX201092H
PKX201561H
PKX201910H
PKX202355H

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

See all →

Critical
Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
Severe
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28

Same hazard · therapy prevention