Medtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect
Medtronic recalled 14 COBALT HF QUAD CRT-D MRI SureScan implantable defibrillators due to a weld crack manufacturing defect detected 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: This is a risk-of-harm cardiac device (implantable defibrillator) with a confirmed manufacturing defect. Although no injuries have been reported and this is an FDA Class II recall, the life-critical nature of the device warrants a High severity rating.
Plain-English summary
Medtronic Inc. is recalling the COBALT HF QUAD CRT-D MRI SureScan (Model Number DTPB2QQ), an implantable cardioverter defibrillator, due to a manufacturing defect. A weld crack in affected units caused them to fail during the manufacturing leak check step.
Fourteen devices have been identified as part of this recall. The affected devices were distributed across multiple U.S. states and internationally to numerous countries.
Patients who may have received one of these devices should contact their healthcare provider or Medtronic directly to determine whether their specific device is affected and to discuss appropriate next steps.
The recalled product
- Product
- COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Hazard
- Affected units
- 14
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 (16)
- GTIN: 00763000178192
- Serial Numbers: RTK624593S
- RTK624594S
- RTK624595S
- RTK624596S
- RTK624597S
- RTK624599S
- RTK624601S
- RTK624602S
- RTK624603S
- RTK624604S
- RTK624606S
- RTK624607S
- GTIN: 00763000711207
- Serial Numbers: RTK624400S
- RTK624405S.
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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