Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode
Medtronic is recalling specific dual chamber pacemakers distributed worldwide between 2017 and 2019 due to a potential circuit error affecting 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 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, specifically the ATTESTA L DR MRI SureScan models (ATDR01, ATDRL1, and ATDRS1). These devices were distributed worldwide between March 10, 2017, and January 7, 2019, under the brand names Adapta, Versa, and Sensia.
The recall is issued because these pacemakers may experience a circuit error that affects device functionality when programmed to a dual chamber mode with atrial-sensing. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Patients with these specific pacemaker models should contact their healthcare provider or Medtronic for instructions on how to monitor the device and determine if any corrective action is necessary.
The recalled product
- Product
- Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
- Category
- Medical Device — Pacemaker
- Affected units
- 9,915
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 (11)
- ATTESTA L DR MRI SureScan
- Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01
- GTIN: 00643169882911
- 00763000109059
- All Serial Numbers (b) Model Number ATDRL1
- GTIN: 00643169882928
- 00763000109066
- All Serial Numbers (c) Model Number ATDRS1
- GTIN: 00643169882935
- 00763000109073
- 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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