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.
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: 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.
- Affected units
- 9
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
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.
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