Severe FDA (Devices)·Z-1760-2023·Announced 2023-06-28

Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

Certain Medtronic implantable cardioverter defibrillators (ICDs and CRT-Ds) may fail to deliver critical therapy due to a manufacturing defect in the feedthrough. This rare issue affects 23,223 devices.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall classification establishes a minimum severity of 4. While the manufacturer characterizes the malfunction risk as rare and no illnesses have been reported, the potential for therapy failure in a life-critical implantable cardiac device justifies this classification.

Plain-English summary

Medtronic is recalling certain CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) containing a specific glassed feedthrough component. Approximately 23,223 units have been distributed in the United States and worldwide.

There is a rare potential for these devices to produce reduced or no-energy output during high-voltage (HV) therapy, typically in the 0-12 joule range. This defect is in a specific feedthrough component used during manufacturing. If the device fails to deliver therapy, it could prevent critical shock therapy from being administered when needed.

Patients with affected devices should contact their healthcare provider or Medtronic immediately to discuss individual risk and determine whether device replacement or additional monitoring is appropriate. The manufacturer provides lot serial numbers to identify affected devices. Patients should not attempt device replacement without medical guidance.

The recalled product

Product: CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardiovascular Devices
Hazard: therapy-failure
device-defect
Affected units: 23,223

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 00643169720640
Lot Serial Numbers: RPB618471S
RPB621777S
RPB619798S
RPB622872S
RPB620883S
RPB621725S
RPB612828S
RPB605719S
RPB615701S
RPB605409S
RPB609214S
RPB619400S
RPB611888S
RPB603955S
RPB617094S
RPB610684S
RPB603737S
RPB603739S
RPB603852S

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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Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
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Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
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Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
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Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
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Same hazard · therapy failure