Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode
Medtronic is recalling specific Versa, Adapta, and Sensia pacemakers distributed worldwide from 2017 to 2019 due to a potential circuit error that may affect device functionality.
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 high-risk medical device (pacemaker) with a functional defect that could impact patient safety, but the source text does not report any injuries, illnesses, or deaths, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling a subset of dual chamber implantable pulse generators, including the Versa, Adapta, and Sensia models, distributed worldwide between March 10, 2017, and January 7, 2019. The recall involves 2,040 units, specifically the Versa Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01, with all serial numbers affected.
The recall is issued because these devices, when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Patients with these specific pacemaker models should contact their healthcare provider or Medtronic for guidance on monitoring the device and determining if a replacement or other action is necessary.
The recalled product
- Product
- Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
- Category
- Medical Device — Pacemaker
- Affected units
- 2,040
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 (7)
- Versa
- Dual chamber rate responsive pacemaker (DDDR)
- Model Number VEDR01
- GTIN: 00643169708969
- 00643169708983
- 00643169709072
- 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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