Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular...
FDA Device Recall #Z-2416-2018 — Class II — June 21, 2018
Recall Summary
| Recall Number | Z-2416-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 21, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Location | Mounds View, MN |
| Product Type | Devices |
| Quantity | 103 units |
Product Description
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. 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.
Distribution Pattern
Worldwide Distribution - US Nationwide
Lot / Code Information
Product UPN/GTIN: 00721902791130 Serial Numbers: PNR100502Q PNR100510Q PNR100522Q PNR100535Q Product UPN/GTIN: 00721902791147 Serial Numbers: PNR100129Q PNR100130Q PNR100131Q PNR100134Q PNR100135Q PNR100138Q PNR100139Q PNR100141Q PNR100143Q PNR100144Q PNR100146Q PNR100147Q PNR100150Q PNR100151Q PNR100153Q PNR100154Q PNR100155Q PNR100156Q PNR100157Q PNR100160Q PNR100161Q PNR100162Q PNR100163Q PNR100164Q PNR100165Q PNR100166Q PNR100167Q PNR100168Q PNR100169Q PNR100174Q PNR100175Q PNR100176Q PNR100178Q PNR100182Q PNR100183Q PNR100184Q PNR100185Q PNR100188Q PNR100191Q PNR100192Q PNR100193Q PNR100195Q PNR100196Q PNR100197Q PNR100198Q PNR100200Q PNR100204Q PNR100208Q PNR100210Q PNR100211Q PNR100212Q PNR100213Q PNR100215Q PNR100216Q PNR100217Q PNR100218Q PNR100219Q PNR100220Q PNR100221Q PNR100222Q PNR100223Q PNR100224Q PNR100225Q PNR100226Q PNR100227Q PNR100228Q PNR100229Q PNR100230Q PNR100233Q PNR100234Q PNR100236Q PNR100237Q PNR100238Q PNR100239Q PNR100241Q PNR100242Q PNR100243Q PNR100244Q PNR100245Q PNR100247Q PNR100249Q PNR100252Q PNR100253Q PNR100254Q PNR100256Q PNR100259Q PNR100261Q PNR100262Q PNR100263Q PNR100264Q PNR100266Q PNR100267Q PNR100270Q Product UPN/GTIN: 00885074299907 Serial Numbers: PNR419863H Product UPN/GTIN: 00885074300207 Serial Numbers: PNR406072H PNR406348H PNR406416H PNR407438H PNR407439H
Other Recalls from Medtronic Inc., Cardiac Rhythm and He...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1707-2023 | Class I | ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Num... | May 10, 2023 |
| Z-1737-2023 | Class I | CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Numbe... | May 10, 2023 |
| Z-1722-2023 | Class I | ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model N... | May 10, 2023 |
| Z-1746-2023 | Class I | CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number... | May 10, 2023 |
| Z-1739-2023 | Class I | CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model ... | May 10, 2023 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.