Reported Dec 22, 2021 · Terminated
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
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 Astra XT DR Implantable pulse generator
- Lot codes and dates
Astra XT DR implantable pulse generatorProduct Number/CFN X2DR01UDI 00763000108953
- Serial Numbers
RNH655287SRNH648107SRNH645452SRNH634608SRNH642593SRNH638740SRNH635040SRNH636809SRNH633755S UDI 00643169634671
- Serial NumbersRNH612514S
- Amount recalled
- 10 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.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.