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.
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 high-risk medical device (pacemaker) with a functional defect that could impact patient safety, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
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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