Medtronic COBALT XT Heart Devices Recalled Due to Manufacturing Defect
Medtronic is recalling 58 COBALT XT HF QUAD implantable cardioverter defibrillators worldwide due to a weld crack manufacturing defect that caused devices to fail 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: This is an FDA Class II recall of life-critical implantable cardioverter defibrillators with a manufacturing defect that poses a risk-of-harm to patients. No injuries or illnesses have been reported to date. The weld crack causes device failure, which could compromise critical cardiac monitoring and treatment functions.
Plain-English summary
Medtronic Inc. is recalling the COBALT XT HF QUAD CRT-D MRI SureScan implantable cardioverter defibrillator (Model DTPA2QQ) due to a manufacturing defect. This recall has been assigned FDA number Z-2194-2024 and is classified as Class II. A total of 58 affected units have been identified.
The recalled devices contain a weld crack that caused them to fail the leak check during the manufacturing process. The leak check is a quality assurance step performed on devices before they are cleared for distribution.
The 58 affected devices have been distributed worldwide, including throughout the United States in California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas, and Virginia. International distribution also includes Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Iceland, Ireland, Italy, Latvia, Netherlands, Northern Ireland, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, and United Kingdom.
Patients with one of these devices should contact their healthcare provider or Medtronic Inc. for guidance. Healthcare providers can identify affected devices using the product model number and the device serial numbers provided in the recall alert.
The recalled product
- Product
- COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Cardiac Device
- Affected units
- 58
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: 00763000178093
- Serial Number: RTC656756S
- GTIN: 00763000178116
- Serial Numbers: RTC656044S
- RTC656047S
- RTC656049S
- RTC656061S
- RTC656065S
- RTC656070S
- RTC656072S
- RTC656099S
- RTC656100S
- RTC656102S
- RTC656103S
- RTC656104S
- RTC656105S
- RTC656106S
- RTC656107S
- GTIN: 00763000711160
- Serial Numbers: RTC655925S
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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