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.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a…"
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.
See all 7 products in this recall →Related recalls
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Same hazard · circuit error
See all →- SevereMedtronic SENSIA Dual Chamber Pacemaker Recall for Circuit Error
FDA (Devices) · 2019-02-20
- SevereMedtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode
FDA (Devices) · 2019-02-20
- SevereMedtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode
FDA (Devices) · 2019-02-20
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- SevereMedtronic Adapta Dual Chamber Pacemaker Recall for Circuit Error
FDA (Devices) · 2019-02-20
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