Medtronic COBALT DR MRI ICD Recalled for Manufacturing Defect
Nine Medtronic COBALT DR MRI implantable cardioverter defibrillators are recalled due to a weld crack that caused devices to fail manufacturing quality checks.
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 device with a documented manufacturing defect (weld crack) detected during quality control. No illnesses or injuries have been reported. The defect poses a potential risk to device function, but actual patient harm has not been documented.
Plain-English summary
Medtronic Inc. is recalling nine COBALT DR MRI SureScan implantable cardioverter defibrillators (Model DDPB3D1) due to a manufacturing defect.
The defect involves a weld crack that caused the affected devices to fail the leak check step during manufacturing quality control.
Nine units have been identified and distributed to the United States (California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas, and Virginia) and numerous international locations. The affected devices are identified by the following serial numbers: RSN604373S, RSN604374S, RSN604375S, RSN604376S, RSN604378S, RSN604380S, RSN604383S, RSN604385S, and RSN604386S.
Patients or healthcare providers who have received one of these devices should contact Medtronic for guidance regarding the defect and to determine what action, if any, is necessary.
The recalled product
- Product
- COBALT DR MRI SureScan, Model Number DDPB3D1, 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 (10)
- GTIN: 00763000711306
- Serial Numbers: RSN604373S
- RSN604374S
- RSN604375S
- RSN604376S
- RSN604378S
- RSN604380S
- RSN604383S
- RSN604385S
- RSN604386S.
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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