Medtronic COBALT DR MRI SureScan ICD Recalled Due to Manufacturing Weld Crack
Medtronic is recalling 36 COBALT DR MRI SureScan implantable cardioverter defibrillators due to a weld crack manufacturing defect. The defect was identified during 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 recall of a high-risk implantable cardiovascular device. The manufacturing defect was identified during manufacturing quality checks before device implantation, limiting potential patient harm.
Plain-English summary
Medtronic Inc. is recalling 36 units of the COBALT DR MRI SureScan, Model Number DDPB3D4, implantable cardioverter defibrillators (ICDs) due to a manufacturing defect involving a weld crack.
The weld crack in the device casing caused affected units to fail leak-check testing during manufacturing. This defect could compromise device integrity and lead to malfunction in patients if not detected.
The affected devices were distributed worldwide, including throughout the United States and in numerous other countries. Specific affected devices are identified by serial number in the regulatory filing.
Patients who have received one of the affected devices should contact their healthcare provider or Medtronic to verify whether they have an affected device and to discuss any necessary follow-up care.
The recalled product
- Product
- COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Hazard
- Affected units
- 36
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 (20)
- GTIN: 00763000178406
- Serial Numbers: RSO618526S
- RSO618555S
- RSO618559S
- GTIN: 00763000711313
- Serial Numbers: RSO618395S
- RSO618396S
- RSO618399S
- RSO618400S
- RSO618401S
- RSO618402S
- RSO618403S
- RSO618405S
- RSO618408S
- RSO618409S
- RSO618410S
- RSO618412S
- RSO618415S
- RSO618416S
- RSO618417S
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
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