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.
What this means for you
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.
- Hazard
- manufacturing-defect
- weld-crack
- device-failure
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.
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