Implantable Defibrillators With Defective Feedthrough May Fail During Critical Therapy
Medtronic is recalling 14,270 implantable cardioverter defibrillators with a specific feedthrough that may produce reduced or no energy output during high-voltage therapy. The affected devices may fail to deliver critical treatment when needed.
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: FDA Class I recall designation requires a minimum severity score of 4. The recalled implantable cardiac devices have a potential to fail during critical high-voltage therapy delivery, which could be life-threatening for patients dependent on these devices for treatment.
Plain-English summary
Medtronic Inc. is recalling 14,270 units of the ICD-VR DVMD3D4 PRIMO MRI implantable cardioverter defibrillator (ICD) and related cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough component. The devices have been distributed nationwide in the US and worldwide.
The recalled devices have a rare potential to produce reduced or no energy output during high-voltage (HV) therapy delivery, typically at 0-12 joules. This defect could prevent the device from delivering the electrical therapy needed to restore normal heart rhythm in patients experiencing life-threatening cardiac arrhythmias.
Patients with implanted devices should verify whether their device is affected by checking their lot serial number against the manufacturer's list of affected lots. Contact Medtronic Inc. for further information regarding this recall.
The recalled product
- Product
- ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
- Affected units
- 14,270
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)
- GTIN 00763000001544
- Lot Serial Numbers: CWL609971S
- CWL607669S
- CWL607665S
- CWL601100S
- CWL608311S
- CWL608330S
- CWL606893S
- CWL611845S
- CWL613316S
- CWL613041S
- CWL613322S
- CWL613037S
- CWL612708S
- CWL610673S
- CWL613504S
- CWL613431S
- CWL610444S
- CWL611258S
- CWL612781S
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 120 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 120 products in this recall →Related recalls
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