Medtronic Adapta Dual Chamber Pacemaker Recall for Circuit Error
Medtronic is recalling specific Adapta, Versa, and Sensia dual chamber pacemakers due to a circuit error that may affect device functionality.
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 classification is Class I, and the rubric mandates a score of at least 4 for FDA Class I recalls, which involve a reasonable probability of serious adverse health consequences.
Plain-English summary
Medtronic Inc. is recalling a subset of dual chamber pacemakers distributed worldwide between March 10, 2017, and January 7, 2019. The affected devices are sold under the brand names Adapta, Versa, and Sensia and include specific model numbers such as ADD01, ADDR01, and ADVDD01.
The recall is being issued because these devices may experience a circuit error when programmed to a dual chamber mode with atrial-sensing. This error may affect the overall functionality of the pacemaker.
Patients with these specific devices should contact their healthcare provider or Medtronic for instructions on how to proceed. The recall covers 41,802 units distributed globally.
The recalled product
- Product
- Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01
- Category
- Medical Device — Pacemaker
- Affected units
- 41,802
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)
- ADAPTA
- Dual chamber pacemaker (DDD): (a) Model Number ADD01
- GTIN: 00643169708754
- All Serial Numbers (b) Model Number ADDR01
- GTIN: 00643169708587
- 00643169708594
- 00643169708600
- 0643169708624
- 00643169969711
- All Serial Numbers (c) Model Number ADDR03
- GTIN: 00643169708631
- 00643169708648
- All Serial Numbers (d) Model Number ADDR06
- GTIN: 00643169708655
- 00643169708662
- All Serial Numbers (e) Model Number ADDRL1
- GTIN: 00643169518247
- 00643169708679
- 00643169708686
- 00643169708709
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
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FDA (Devices) · 2019-02-20
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