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.
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 2/5 (Moderate).
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- ModerateMedtronic SureScan Pacemaker ID Cards Mislabel MR Conditional Status
FDA (Devices) · 2015-10-14
- HighMedtronic Mo.Ma Ultra Cerebral Protection Device Labeling Error
FDA (Devices) · 2023-11-29
- HighMedtronic Mo.Ma Ultra cerebral protection device labeling error recalled
FDA (Devices) · 2023-11-29
- ModerateCardinal Health Recalls S.M.A.R.T. Stents for Incorrect MRI Labeling
FDA (Devices) · 2020-01-01
- HighMedtronic Vectris SureScan MRI lead kits recalled for incorrect labeling
FDA (Devices) · 2021-08-04
- HighMedtronic MIRRO MRI ICD devices recalled for manufacturing weld crack defect
FDA (Devices) · 2024-07-03