February 26, 2018 — The U.S. Food and Drug Administration (FDA) announced that Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) due to a defect in the manufacturing process. The FDA said 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.
On Jan. 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; and
- Review the recall notice and ensure appropriate staff is aware of the notice.
The recall impacts patients with an affected Medtronic ICD or CRT-D device, caregivers of those patients, and healthcare providers treating patients with heart failure or heart rhythm problems using these devices. The recall affects CRT-Ds an ICDs with product codes NIK and LWS, manufactured between July 13, 2013, and Aug. 8, 2017 — a total of 48 units nationwide.
Medtronic will offer a supplemental device warranty for affected devices. 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).
Healthcare 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.
ICDs and CRT-Ds are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. Both types of devices are 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.
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.
See the complete list of affected serial numbers here.
For more information: www.medtronic.com