Reported Oct 14, 2015 · Terminated
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the…
Medtronic Inc. Cardiac Rhythm Disease Management
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 Disease Management · 8200 Coral Sea St NE · Saint Paul, MN · 55112-4391
Is this the product you have?
- 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 messaging regarding the MR conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.
- Lot codes and dates
- no codes on the cards
- Amount recalled
- 777 cards
Where it was sold
- Nationwide
Why it was recalled
Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.
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 Disease Management 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.