Extravascular defibrillators recalled over potential delay in high-voltage therapy delivery
Medtronic is recalling 6,591 Aurora EV-ICD and Clinical EV-ICD single chamber extravascular defibrillators over the potential for delayed time to high-voltage therapy in a rare sequence of events.
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: Scored 3 under the risk-of-harm criterion: a delay in high-voltage therapy from an implanted defibrillator is a potential harm, and no injuries are reported.
Plain-English summary
The Aurora EV-ICD and Clinical EV-ICD, single chamber extravascular implantable cardioverter defibrillators, product number DVEA3E4, from Medtronic, are being recalled.
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
The recall covers 6,591 units across UDI-DIs 00763000368470, 00763000368463, 00763000217907, 00763000217891, 00763000288068 and 00763000744694, with affected serial numbers listed in the enforcement record. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
A delay in delivering high-voltage therapy affects how quickly an implanted defibrillator responds. The enforcement record reports no injuries. Patients should not act on this notice alone and should contact the clinic that manages their device; clinicians should follow Medtronic's instructions.
The recalled product
- Product
- Kidney Test
- Manufacturer
- GET TESTED INTERNATIONAL AB
- Affected units
- 100
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 (4)
- EAN: 7340221701731
- SKU: D-KID
- UDI-DI: None
- Lot/Serial Number: All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 92 recalled by GET TESTED INTERNATIONAL AB 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.
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