Medical Device ID Cards incorrectly printed with MR conditional system statement
Medtronic is recalling 187 Medical Device Identification Cards for Sprint Quattro Lead implants printed with an erroneous statement about MR conditional system status. Affected cards were distributed in the US, Canada, and Northern Mariana Islands.
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: Class II device recall with a labeling error on an informational product. No reported hospitalizations, injuries, or deaths. The erroneous statement is a documentation issue on the identification card rather than a defect in the implanted device itself.
Plain-English summary
Medtronic is recalling Medical Device Identification Cards associated with the Sprint Quattro Lead cardiac device (Product/CFN 6935M72). A total of 187 identification cards were distributed to patients in the US, Canada, and Northern Mariana Islands.
The back of some cards were printed with an erroneous statement: "This patient has a complete MR conditional system implanted." This incorrect information does not accurately reflect the MRI conditional status of all implanted devices.
Patients who received a Sprint Quattro Lead implant and received one of the affected identification cards should consult their healthcare provider or contact Medtronic to verify the correct MR conditional status of their specific device. Healthcare providers should confirm accurate device information with Medtronic or review implant documentation before any procedures involving magnetic resonance.
The recalled product
- Product
- Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
- Hazard
- Affected units
- 187
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 (20)
- Sprint Quattro Lead
- Product/CFN 6935M72
- UDI 00643169550919
- Serial Numbers: TDL440798V
- TDL475850V
- TDL473645V
- TDL386490V
- TDL446689V
- TDL458696V
- TDL398634V
- TDL440035V
- TDL458694V
- TDL397987V
- TDL469404V
- TDL469730V
- TDL469411V
- TDL473637V
- TDL434492V
- TDL433920V
- TDL469403V
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 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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