Agency classClass IIOur severity:High FDA (Devices)·Z-2203-2024·Announced 2024-07-03

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.

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 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.
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: manufacturing-defect
weld-crack
device-failure
Affected units: 46

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.

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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