Agency classClass IOur severity:Severe FDA (Devices)·Z-1774-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy

Some Medtronic implantable defibrillators contain a specific feedthrough that may rarely cause reduced or no energy output during high-voltage therapy. The recall affects approximately 4,151 units distributed nationwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I device recall, which indicates potential for serious adverse health consequences. Although no illnesses or deaths have been reported, the rare potential for complete therapy failure in a life-sustaining implantable device warrants a Severe rating.

Plain-English summary

Medtronic has recalled implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific feedthrough. The CRTD COBALT XT HF MRI IS1 DF1 (Model Number DTPA2D1) is among the recalled devices, with approximately 4,151 units distributed throughout the United States and worldwide.

The recalled devices may rarely produce reduced or no energy output during high-voltage (HV) therapy, typically at energy levels of 0-12 joules. This potential malfunction is related to a specific feedthrough component used in the devices' manufacturing.

Patients who have been implanted with these devices should contact their healthcare provider for further information regarding this recall.

The recalled product

Product: CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiac Device
Hazard: therapy-failure
device-malfunction
Affected units: 4,151

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

GTIN 00763000178147
Lot Serial numbers: RTH601483S
RTH602021S
RTH602022S
RTH602302S
RTH602303S
RTH602305S
RTH602306S
RTH605169S
RTH602089S
RTH603993S
RTH601526S
RTH600467S
RTH600514S
RTH600533S
RTH600607S
RTH600608S
RTH601387S
RTH601543S
RTH601544S

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 120 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 120 products in this recall →

Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

See all →

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Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
Severe
Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
Severe
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28

Same hazard · therapy failure