Implantable Defibrillator Recalled for Manufacturing Weld Crack Defect
Medtronic is recalling 11 units of the COBALT XT HF QUAD CRT-D MRI SureScan implantable cardioverter defibrillator due to a manufacturing defect involving weld cracks that failed 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 an FDA Class II recall of an implantable cardiovascular device with a structural manufacturing defect (weld crack). Although no adverse events have been reported and the defect was identified during manufacturing quality control, this represents a risk-of-harm situation with a critical medical device type.
Plain-English summary
Medtronic Inc. is recalling 11 units of the COBALT XT HF QUAD CRT-D MRI SureScan implantable cardioverter defibrillator, Model DTPA2Q1, due to a manufacturing defect.
The defect involves a weld crack that caused the devices to fail the leak check test during manufacturing. The manufacturing defect was identified during production quality control testing.
The 11 recalled units have been distributed worldwide, including throughout the United States and across multiple international locations including Canada, Australia, and numerous European and Asian countries.
The recalled product
- Product
- COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Affected units
- 11
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 (13)
- GTIN: 00763000178109
- Serial Numbers: RTD607545S
- RTD607549S
- RTD607551S
- GTIN 00763000711177
- Serial Numbers: RTD607363S
- RTD607364S
- RTD607367S
- RTD607369S
- RTD607370S
- RTD607374S
- RTD607404S
- RTD607405S.
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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