Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode
Medtronic is recalling specific dual chamber pacemakers due to a circuit error that may affect device functionality when programmed to atrial-sensing mode.
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 risk-of-harm product (implantable pacemaker) where a circuit error affects functionality, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Inc. is recalling a subset of its dual chamber pacemakers, including models distributed under the brand names Adapta, Versa, and Sensia. The affected devices were distributed worldwide between March 10, 2017, and January 7, 2019. The recall involves 47,086 units across the A, E, G, and Q series.
The recall is being conducted because these pacemakers may experience a circuit error that affects device functionality when programmed to a dual chamber mode with atrial-sensing. This issue is specific to the programming mode mentioned and may impact the device's performance.
Patients with these specific pacemaker models should contact their healthcare provider or Medtronic for guidance on next steps. The source text does not specify a consumer action other than the general implication of a recall, but standard medical device recall procedures typically involve clinical evaluation.
The recalled product
- Product
- vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
- Category
- Medical Device — Pacemaker
- Affected units
- 47,086
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)
- vitatron (implantable pulse generator): (a) A-series
- Model Number: A30A1
- GTIN 00643169709331
- A60A1
- GTIN 00643169709294
- All Serial Numbers (b) E-series
- Model Number: E50A1
- GTIN 00643169709126
- 00643169709140
- E60A1
- GTIN 00643169709164
- 00643169709188
- All Serial Numbers (c) G-series
- Model Numbers: G70A1
- GTIN 00643169709249
- 00643169709263
- G70A2
- GTIN 00643169883000
- All Serial Numbers (d) Q-series
- Model Number: Q50A2
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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