Class 1 Recall: Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery
Recalled Product(s): Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs)
Mon Feb 26 2018
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recalled Product(s): Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs)
- Product Codes: NIK, LWS
- Serial Numbers: See Complete List
- Manufacturing Dates: July 13, 2013 to August 8, 2017
- Devices Recalled in the U.S.: 48 units nationwide
Device Use:
Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called "leads" that go into the heart. Patients need an ICD or CRT-D if their heartbeat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.
Reason for Recall
Medtronic is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process. This defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest.
The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.
Who is affected?
- Patients with an affected Medtronic ICD or CRT-D device
- Caregivers of patients with an affected Medtronic ICD or CRT-D device
- Health care providers treating patients with heart failure or heart rhythm problems using affected Medtronic ICD or CRT-D devices
What to Do:
On January 22 2018 Medtronic sent an Urgent Medical Device Recall notice to affected customers. The notice asked customers to:
- Consider Prophylactic device replacement for patients who have been implanted with one of the affected devices.
- Contact their Medtronic sales representative for terms and conditions for device warranties.
- Review the recall notice and ensure appropriate staff is aware of the notice.
Medtronic will offer a supplemental device warranty for affected devices.
Contact Information
Customers who have questions or need additional information or support regarding this recall should contact their local Medtronic sales representative or Medtronic Technical Services at 800-723-4636.
Patients can contact Medtronic Patient Services at 800-551-5544 (Monday-Friday, 8am-5pm Central Time).
Date Recall Initiated
January 22, 2018
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
Complete List of Serial Numbers
Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) |
Device Model |
Device Serial Number |
---|---|---|
Amplia MRI CRT-D DF4 | DTMB1D4 | RPJ201956H |
Amplia MRI Quad CRT-D DF4 | DTMB1QQ |
RPE201417H RPE204789H RPE206207H RPE207850H RPE209095H RPE212027H |
Claria MRI Quad CRT-D DF4 | DTMA1QQ | RPA204495H |
Compia MRI Quad CRT-D DF4 | DTMC1QQ | RPL201034H |
Viva Quad S CRT-D DF4 | DTBB1QQ | BLK204122H |
Viva Quad XT CRT-D DF4 | DTBA1QQ |
BLC224272H BLC227175H BLC227641H |
Viva S CRT-D DF1 | DTBB1D1 | BLO204984H |
Viva XT CRT- D DF1 | DTBA1D1 |
BLF216780H BLF231229H BLF250740H BLF251155H BLF255165H |
Viva XT CRT- D DF4 | DTBA1D4 | BLE220200H |
Implantable Cardiovert- Defibrillators (ICDs) |
Device Model |
Device Serial Number |
---|---|---|
Evera MRI XT DR ICD DF1 | DDMB1D1 |
CWA200012H CWA202259H CWA203498H |
Evera MRI XT DR ICD DF4 | DDMB1D4 |
PFZ214605H PFZ228504H PFZ228590H PFZ228836H PFZ228838H PFZ229236H |
Evera MRI XT VR ICD DF4 | DVMB1D4 |
PKZ203327H PKZ210673H |
Evera MRI S DR ICD DF1 | DDMC3D1 | CWC200055H |
Evera S DR ICD DF1 | DDBC3D1 | BWG204574H |
Evera S VR ICD DF1 | DVBC3D1 | BWM204635H |
Evera XT DR ICD DF1 | DDBB1D1 |
BWC223253H BWC233374H BWC234767H BWC234772H |
Evera XT VR ICD DF1 | DVBB1D1 | BWI208876H |
Evera XT VR ICD DF4 | DVBB1D4 |
BWH201158H BWH214640H |
Visia AF MRI VR SureScan ICD DF1 | DVFB1D1 | CWG200402H |
Visia AF MRI VR SureScan ICD DF4 | DVFB1D4 |
PKX202448H PKX205417H PKX205779H PKX209277H PKX212710H |
Visia AF VR ICD DF1 | DVAB1D1 | BWN201126H |