Medtronic Cobalt XT DR MRI cardioverter defibrillator battery testing defect
Medtronic is recalling Cobalt XT DR MRI implantable cardioverter defibrillators due to a manufacturing defect in the battery testing process. Some batteries may have bypassed required validation.
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 life-support device due to a manufacturing defect in the battery testing process. While the potential for device malfunction exists and could have serious consequences, no illnesses, injuries, or deaths have been reported, placing this at the High severity level per FDA rubric guidelines.
Plain-English summary
Medtronic Inc. is recalling the Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator (model DDPA2D1, Serial Number RSL604096S) due to a defect in the battery testing process. During an internal review of battery assembly data, Medtronic engineers discovered that some batteries had been subjected to HiPot (High Potential) testing twice. This occurred because the testing system did not prevent retesting after a failure. Some batteries were therefore retested and subsequently passed the test.
The issue is that batteries intended to receive a single HiPot test may not have been properly validated. A properly functioning battery is critical to the safe and reliable operation of an implantable cardioverter defibrillator, a device that monitors heart rhythm and delivers corrective therapy when needed.
The affected device was distributed in Florida. Patients who have received this implant should contact their healthcare provider or Medtronic Inc. for further guidance regarding evaluation and any necessary follow-up care.
The recalled product
- Product
- Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
- Manufacturer
- Medtronic Inc.
- Affected units
- 1
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 (2)
- UDI/DI 00763000178338
- Serial Number RSL604096S
Distribution
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