Medtronic Implantable Defibrillator Recalled Due to Manufacturing Weld Crack
Medtronic is recalling 14 Cobalt XT HF CDT-D MRI SureScan implantable defibrillators due to a manufacturing weld defect that could cause device failure.
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 medical device recall involving a life-critical implantable device. While no illnesses or injuries have been reported, the manufacturing defect poses a significant risk of device failure in potentially implanted units, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling 14 units of the Cobalt XT HF CDT-D MRI SureScan Model DTPA2D4, an implantable cardioverter defibrillator (ICD). The devices were distributed worldwide, including to the United States, Australia, Canada, and multiple European countries.
The devices are being recalled due to a manufacturing defect: a weld crack in the device structure. This defect caused the devices to fail leak-check testing during manufacturing, which is a critical quality-assurance step to ensure device integrity.
The 14 affected units are identified by their serial numbers (RTG612496S through RTG612556S). Patients who have received these specific devices or healthcare providers with these devices in inventory should contact Medtronic immediately for guidance. Patients should not stop using their devices without medical direction.
The recalled product
- Product
- Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- 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 (15)
- GTIN: 00763000178130
- Serial Numbers: RTG612496S
- RTG612497S
- RTG612498S
- RTG612499S
- RTG612502S
- RTG612503S
- RTG612504S
- RTG612505S
- RTG612509S
- RTG612512S
- RTG612513S
- RTG612549S
- RTG612553S
- RTG612556S.
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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