Medtronic Model 53401 Pacemakers Recalled for Unexpected Power Reset
Medtronic is recalling 1,108 Model 53401 temporary external pacemakers because they may revert to nominal settings during use due to an unexpected power on reset.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a medical device failing to maintain programmed settings, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Inc. is recalling 1,108 units of the Single Chamber Temporary External Pacemaker, Model 53401. The recall is due to a defect where a subset of these devices may revert from programmed settings to nominal settings during use with a patient. This issue is caused by an unexpected Power on Reset (POR) event.
The affected devices were distributed domestically to 46 US states and the District of Columbia, as well as internationally to 35 countries. The recall covers specific serial numbers listed in the FDA record Z-2317-2018.
Healthcare providers and consumers should check their device serial numbers against the recall list. If a device is affected, it should be removed from service and returned to Medtronic for evaluation or replacement according to the company's instructions.
The recalled product
- Product
- Single Chamber Temporary External Pacemaker, Model 53401
- Affected units
- 1,108
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)
- Serial Numbers MDB01005EP
- MDB01006EP
- MDB01007EP
- MDB01008EP
- MDB01009EP
- MDB01010EP
- MDB01011EP
- MDB01012EP
- MDB01013EP
- MDB01014EP
- MDB01015EP
- MDB01016EP
- MDB01017EP
- MDB01018EP
- MDB01019EP
- MDB01036EP
- MDB01037EP
- MDB01038EP
- MDB01039EP
- MDB01040EP
Distribution
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