August 19, 2022 — According to a release just issued by the U.S. Food and Drug Administration (FDA), Medtronic is recalling Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Resynchronization Therapy Defibrillators (CRT-Ds) after receiving reports that some devices have triggered short circuit protection (SCP) alerts during the second phase of high voltage waveform therapy and delivered reduced-energy electric shocks.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
According to a Medtronic spokesperson, Medtronic has received FDA approval and CE Mark for a software update to help mitigate this issue. The company began deploying the update into already-implanted Cobalt XT, Cobalt, and Crome devices via in-clinic device checks in mid-August 2022. Newly manufactured devices will have the update pre-installed starting this month.
- Product Name: Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
- Model Numbers (See recall database entry for more information):
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
- Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
- Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
- Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
- Devices Being Recalled: 87,709
- Dates distributed: February 3, 2020 to Present
- Date Initiated by Firm: June 22, 2022
Medtronic Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are implantable cardiac devices that are intended to monitor and regulate heart rate and rhythm. These devices can deliver a pacing impulse to correct a slow heartbeat (bradycardia), provide biventricular pacing/cardiac resynchronization therapyExternal Link Disclaimer, or produce an electric shock (cardioversion or defibrillation) to restore a regular heartbeat if a life-threatening arrhythmia occurs.
Reason for Recall
Medtronic is recalling Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Resynchronization Therapy Defibrillators (CRT-Ds) after receiving reports of devices with a short circuit protection (SCP) alert resulting in reduced-energy electric shock delivery, instead of delivering a second phase of high voltage therapy.
A reduced-energy electrical shock may fail to correct an irregular heartbeat (arrythmia) or may cause an irregular heartbeat. The harms associated with a reduced-energy electric shock or an inaccurate response to an SCP alert may cause serious injury or death.
There have been 27 complaints, no injuries, and no deaths associated with this issue.
Who May Be Affected
- Patients who have been implanted with Cobalt and Crome ICDs and CRT-Ds
- Clinicians who implant and manage patients with Cobalt and Crome ICDs and CRT-Ds
What to Do
On June 22, 2022, Medtronic issued a communication to customers. The communication offered the following patient management recommendations and considerations to customers and/or users:
- Do not prophylactically replace devices for this issue.
- Remotely monitor patients following normal clinical protocol follow-up.
- Encourage patients to attend their next scheduled follow-up in-clinic for device reprogramming (if necessary).
- Programming all high voltage therapies to 40J with a B>AX pathway and Active Can/SVC Coil set with Active Can enabled across all therapy zones.
- A software update to correct the issue will be available in late 2022. Another in-clinic follow-up will be needed when the software update is available so it can be installed into a patient’s device. The update will ensure the full shock energy is delivered in the presence of a secondary, low-level current pathway in the high voltage circuitry.
- Be aware, the following are signs that a short circuit alert is a result of a reduced-energy shock and not a problem with a device’s leads
- If the delivered energy during the episode is ~79% of the programmed energy AND the SCP alert indicates an RV Defib Lead impedance alert reporting exactly zero (0) ohms, this is an indication of a second-phase SCP event (as described in this letter) and not a lead issue.
- Contact Medtronic Technical Services (1-800-723-4636) or your local representative if an RV Defib Lead Impedance Alert reporting zero (0) ohms is observed. This is an indicator that an SCP event was detected during HV therapy.
- Consider device replacement only after observing and confirming the cause of an SCP event with a Medtronic representative.
- Note that several device functions are not impacted after an SCP alert:
- Episode detection
- Anti-tachycardia pacing therapies
- High voltage charging
- Battery longevity
- Bluetooth telemetry
Customers with questions or concerns about this recall should contact Medtronic Technical Services (1-800-723-4636) or their local Medtronic representative.