Medtronic SENSIA Dual Chamber Pacemaker Recall for Circuit Error
Medtronic is recalling SENSIA dual chamber pacemakers due to a potential circuit error that may affect device functionality when programmed to specific modes.
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 source text explicitly identifies this as an FDA Class I recall. Per the rubric, FDA Class I recalls are assigned a severity score of 4 (Severe) or higher, as they represent a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Medtronic Inc. is recalling a subset of SENSIA dual chamber pacemakers (models SED01, SEDR01, and SEDRL1) distributed worldwide between March 10, 2017, and January 7, 2019. The recall involves 59,232 units sold under the brand names Adapta, Versa, and Sensia.
The recall is issued because these devices may experience a circuit error that affects device functionality when programmed to a dual chamber mode with atrial-sensing. This is classified as an FDA Class I recall.
Patients with these specific pacemaker models should contact their healthcare provider or Medtronic for further instructions regarding the device's status and necessary actions.
The recalled product
- Product
- Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
- Category
- Medical Device — Pacemaker
- Affected units
- 59,232
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)
- SENSIA
- Dual chamber pacemaker (DDD): (a) Model Number SED01
- GTIN 00643169708914
- All Serial Numbers (b) Model Number SEDR01
- GTIN 00643169708877
- 00643169708891
- 00643169969780
- All Serial Numbers (c) Model Number SEDRL1
- GTIN 00643169708907
- 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.
See all 7 products in this recall →Related recalls
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Same hazard · circuit error
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FDA (Devices) · 2019-02-20
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