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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D)."
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…
- 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 →Related recalls
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See all →- SevereMedtronic Recalls Claria MRI CRT-Ds Due to Therapy Prevention Risk
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