Agency classClass IIOur severity:High FDA (Devices)·Z-2199-2024·Announced 2024-07-03

Implantable Cardioverter Defibrillator with Weld Crack Defect Recalled

Medtronic is recalling 40 EVERA MRI S DR SureScan ICDs (Model DDMC3D4) due to manufacturing weld cracks that caused devices to fail leak tests. The defect was identified during manufacturing; no patient harm has been reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a life-critical implantable device due to a manufacturing defect (weld crack) that could cause device failure. The defect was identified during manufacturing quality control with no reported patient harm, placing it in the "risk-of-harm product where injury has not been reported" category.

Plain-English summary

Medtronic Inc. is recalling 40 units of the EVERA MRI S DR SureScan implantable cardioverter defibrillator (ICD), Model Number DDMC3D4, due to a manufacturing defect.

A weld crack in the manufacturing process caused some devices to fail the leak check test during production. The defect was identified and contained during manufacturing, before the devices reached patients.

The recalled units were distributed worldwide, including in 15 U.S. states and multiple countries. Patients and healthcare providers should check the provided serial number list to determine if a device is affected.

Patients with a recalled device should contact Medtronic or their healthcare provider immediately for guidance on next steps.

The recalled product

Product: EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
Manufacturer: Medtronic Inc.
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: manufacturing-defect
weld-crack
device-failure
Affected units: 40

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: 00763000206185
Serial Numbers: PHZ659606S
PHZ659607S
PHZ659610S
PHZ659611S
PHZ659612S
PHZ659666S
PHZ659667S
PHZ659693S
PHZ659694S
PHZ659696S
PHZ659707S
PHZ659729S
PHZ659745S
PHZ659749S
PHZ659750S
PHZ659753S
PHZ659754S
PHZ659755S
PHZ659803S

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 23 recalled by Medtronic Inc. 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 23 products in this recall →

Same manufacturer · Medtronic Inc.

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