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.
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 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.
See all 23 products in this recall →Related recalls
Same manufacturer · Medtronic Inc.
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateKidney tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighSmartSync Patient Connector limited the window to abort high voltage therapy
FDA (Devices) · 2025-07-30
- HighCareLink SmartSync limited the window to abort a high voltage therapy
FDA (Devices) · 2025-07-30
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUnited Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System
FDA (Devices) · 2026-08-12
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12