Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 18, 2018
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ve… - a moderate-severity action.
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ve… was recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) in July 18, 2018. Reason: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnT…. Check the official notice for the remedy. Verify recall #Z-2418-2018 with the FDA Devices before acting.
The recall
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) issued this moderate-severity FDA Devices recall-Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnT….
- Moderate
- severity level
- 3 units
- affected scope
- Class II
- classification
- July 18, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2418-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2418-2018) was formally reported on July 18, 2018, with the manufacturer initiating the action on June 21, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is listed as the recalling firm, operating out of Mounds View, MN. Federal records list the affected scope as 3 units.
The documented reason for this recall is: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ER… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3 units
Related Recalls
6
0 from same agency
Product description
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Reason for recall
Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2418-2018 |
| Date reported | July 18, 2018 |
| Date initiated | June 21, 2018 |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Firm location | Mounds View, MN |
| Affected scope | 3 units |
| Distribution | Worldwide Distribution - US Nationwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2418-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 3 units.
Why was this product recalled? ▼
Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 18, 2018. Severity: Moderate. Recall number: Z-2418-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2418-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 18, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.