Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect
Medtronic recalls 46 PRIMO MRI VR SureScan implantable cardioverter defibrillators due to a manufacturing defect. Weld cracks identified during manufacturing quality checks could cause device failure.
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 for a high-risk implantable cardiac device with a confirmed manufacturing defect (weld crack) that could lead to device failure. No illnesses or injuries have been reported, and the defective devices were identified and stopped during manufacturing quality checks before distribution. This meets the rubric criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling 46 units of the PRIMO MRI VR SureScan implantable cardioverter defibrillator (Model DVMD3D4) due to a manufacturing defect involving potential weld cracks that could cause device failure.
The manufacturing defect was discovered during manufacturing when devices failed leak-check testing, a critical quality-control procedure. The weld cracks led to devices failing this test.
The recalled devices were distributed worldwide to healthcare facilities, including US states CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, and VA, and to multiple international countries including Australia, Austria, Bulgaria, Canada, China, and others. Affected devices can be identified by specific serial numbers provided by Medtronic.
This is a Class II recall issued by the FDA.
The recalled product
- Product
- PRIMO MRI VR SureScan, Model Number DVMD3D4, 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: 00763000611965
- Serial Numbers: CWL619625S
- CWL619626S
- CWL619627S
- CWL619631S
- CWL619632S
- CWL619633S
- CWL619634S
- CWL619635S
- CWL619636S
- CWL619637S
- CWL619638S
- CWL619639S
- CWL619640S
- CWL619641S
- CWL619642S
- CWL619645S
- CWL619648S
- CWL619649S
- CWL619650S
Distribution
Distributed nationwide across the United States.
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