Medtronic COBALT VR MRI SureScan implantable defibrillators recalled for manufacturing defect
Medtronic is recalling 4 COBALT VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing defect involving a weld crack identified during quality control 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 of an implanted cardiac device where a manufacturing defect (weld crack) poses a risk of device failure. No illnesses or injuries have been reported, and all affected units were caught during manufacturing quality control. The theoretical risk in a critical implanted device warrants High severity.
Plain-English summary
Medtronic Inc. is recalling 4 units of the COBALT VR MRI SureScan, Model Number DVPB3D4, an implantable cardioverter defibrillator (ICD). The recall is due to a manufacturing defect: a weld crack was identified during the leak check step of the manufacturing process, causing the devices to fail that quality control test.
The weld crack poses a potential risk of device failure if the defect had not been detected. All 4 affected units were identified and stopped during manufacturing; no devices reached patients. The affected serial numbers are RSF612135S, RSF612143S, RSF612097S, and RSF612098S.
The recalled devices were distributed in the following U.S. states: California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas, and Virginia. International distribution included Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Patients with these devices should contact their physician or Medtronic to confirm whether they are affected. Healthcare providers should use the serial numbers to identify affected devices and coordinate with Medtronic regarding further action.
The recalled product
- Product
- COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Affected units
- 4
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 (6)
- GTIN: 00763000178512
- Serial Numbers: RSF612135S
- RSF612143S
- GTIN: 00763000711375
- Serial Numbers: RSF612097S
- RSF612098S.
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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