Medtronic COBALT XT HF CRT-D implantable defibrillator recalled for manufacturing defects
Medtronic is recalling 8 units of the COBALT XT HF CRT-D MRI SureScan implantable cardioverter defibrillator due to manufacturing defects identified during quality control testing.
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: This is a Class II recall of an implantable life-critical medical device with an identified manufacturing defect (weld cracks). No illnesses or injuries have been reported. Per the rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High (3) severity score.
Plain-English summary
Medtronic Inc. is recalling 8 units of the COBALT XT HF CRT-D MRI SureScan implantable cardioverter defibrillator (Model DTPA2D1) due to a manufacturing defect.
The defect involves weld cracks in the device that caused failures during the leak check testing step in manufacturing. These affected units were identified with specific serial numbers and distributed to healthcare facilities.
The recalled units were distributed to multiple locations across the United States including California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas, and Virginia, as well as internationally in 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 the United Kingdom.
Patients and healthcare providers with these devices should consult their physician or Medtronic for guidance regarding device status and any necessary actions.
The recalled product
- Product
- COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Affected units
- 8
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: 00763000178147
- Serial Numbers: RTH608902S
- RTH608907S
- RTH608911S
- RTH608923S
- RTH608935S
- RTH608966S
- GTIN: 00763000711191
- Serial Numbers: RTH609509S
- RTH609510S.
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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