Reported Dec 22, 2021 · Terminated
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
- Lot codes and dates
Sprint Quattro LeadProduct/CFN 6935M72UDI 00643169550919
- Serial Numbers
178 of 178 codes
TDL440798VTDL475850VTDL473645VTDL386490VTDL446689VTDL458696VTDL398634VTDL440035VTDL458694VTDL397987VTDL469404VTDL469730VTDL469411VTDL473637VTDL434492VTDL433920VTDL469403VTDL397982VTDL448256VTDL398632VTDL424268VTDL448531VTDL458699VTDL460247VTDL410929VTDL405398VTDL440809VTDL448519VTDL410295VTDL410332VTDL445702VTDL368164VTDL378146VTDL446690VTDL386481VTDL458695VTDL448518VTDL448258VTDL433896VTDL446674VTDL397974VTDL386494VTDL429017VTDL397966VTDL369718VTDL424266VTDL445620VTDL445705VTDL440984VTDL440027VTDL386489VTDL403279VTDL405769VTDL434493VTDL440803VTDL445618VTDL448527VTDL433902VTDL440971VTDL440977V
- Serial Numbers
TDL098796VTDL046363VTDL016560VTDL016558VTDL016557VTDL002704VTDL010685V UDI 00643169309784
- Serial Numbers
TDL192485VTDL187462V
- Amount recalled
- 187 Medical Device Cards
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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