Medtronic Pacemaker Recall: Circuit Error Affects Dual Chamber Functionality
Medtronic is recalling 7,469 dual chamber pacemakers worldwide due to a circuit error that may affect device functionality when programmed to specific modes.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, a circuit error in an implantable cardiac device represents a significant risk of harm.
Plain-English summary
Medtronic Inc. is recalling 7,469 units of RELIA, Dual chamber pacemakers (VDD) distributed worldwide between March 10, 2017, and January 7, 2019. The affected models are RED01, REDR01, and REVDD01, which were sold under the brand names Adapta, Versa, and Sensia.
The recall is due to a potential circuit error that may affect device functionality. This issue may occur when the pacemakers are programmed to a dual chamber mode with atrial-sensing.
Patients with these specific devices should contact their healthcare provider or Medtronic to determine if their device is affected and to discuss appropriate next steps.
The recalled product
- Product
- Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
- Affected units
- 7,469
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 (10)
- RELIA
- Dual chamber pacemaker (VDD): (a) Model Number RED01
- GTIN: 00643169709003
- All Serial Numbers (b) Model Number REDR01
- GTIN: 00643169708990
- 00643169969742
- All Serial Numbers (c) Model Number REVDD01
- GTIN: 00643169709010
- 00643169969773
- All Serial Numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 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.
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