Medtronic SureScan Pacemaker ID Cards Mislabel MR Conditional Status
Medtronic is recalling 777 identification cards for SureScan pacemaker patients that incorrectly indicate the entire system is MR Conditional.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding MR conditional status. No injuries or illnesses are reported in the source text, fitting the criteria for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Medtronic Inc. Cardiac Rhythm Disease Management is recalling 777 Medical Device Identification Cards provided to SureScan pacemaker patients. These cards are distributed nationwide in the United States.
The recall is due to a labeling error on the cards. The front of the card identifies the implanted pacing system components, while the back lists the patient's physician and specific messaging regarding the MR conditional status of the device components. The recalled cards incorrectly indicate that the patient has a complete Magnetic Resonance (MR) Conditional system. In reality, not all of the implanted leads for these patients have been FDA approved as MR Conditional.
Patients who received these cards should contact their physician or Medtronic for accurate information regarding the MR conditional status of their specific implanted leads. The cards do not have specific codes on them.
The recalled product
- Product
- Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messa
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Hazard
- Affected units
- 777
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 (1)
- no codes on the cards
Distribution
Distributed nationwide across the United States.
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