Medtronic ICD Implants Recalled for Manufacturing Weld Crack Defects
Medtronic recalls 9 units of CROME VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing weld crack that caused devices to fail quality control leak testing.
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: FDA Class II recall affecting a critical life-sustaining implantable device. The manufacturing weld crack defect presents a potential risk of device malfunction that could affect cardiac function. No illnesses or injuries have been reported to date, and devices were detected and failed at manufacturing quality control.
Plain-English summary
Medtronic Inc. is recalling 9 units of the CROME VR MRI SureScan Model DVPC3D1 implantable cardioverter defibrillator (ICD). The device is designed to monitor and regulate heart rhythm in patients with certain cardiac conditions.
A manufacturing defect involving a weld crack has been identified in these devices. The defect caused the affected units to fail the leak check step during manufacturing quality control testing.
The recalled devices were distributed worldwide, including across 15 U.S. states and multiple international locations. Patients who have received one of the recalled devices should contact Medtronic or their healthcare provider for instructions on next steps.
The specific serial numbers of affected devices are RSG601442S, RSG601443S, RSG601445S, RSG601446S, RSG601449S, RSG601461S, RSG601467S, RSG601478S, and RSG601428S.
The recalled product
- Product
- CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Hazard
- manufacturing-defect
- 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 (11)
- GTIN: 00763000178543
- Serial Numbers: RSG601442S
- RSG601443S
- RSG601445S
- RSG601446S
- RSG601449S
- RSG601461S
- RSG601467S
- RSG601478S
- GTIN: 00763000711382
- Serial Number: RSG601428S.
Distribution
Distributed nationwide across the United States.
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