Food, drugs, devices › Medtronic Inc. Cardiac Rhythm Disease Management
Device recall: Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the impl
FDA enforcement event 72245 is a device recall by Medtronic Inc. Cardiac Rhythm Disease Management of Saint Paul, MN, initiated 15 Sep 2015 and classified Class II, with 1 product record.
FDA defines Class II as 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 14 Apr 2016. Initiation: voluntary: firm initiated. Medtronic Inc. Cardiac Rhythm Disease Management has 16 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN.
Reason for recall
"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."
Distribution
"US nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0022-2016 | 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… | 777 cards | Class II | Terminated | 14 Oct 2015 |
Context
Other enforcement events for Medtronic Inc. Cardiac Rhythm Disease Management
All 16 events for Medtronic Inc. Cardiac Rhythm Disease Management
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Apr 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.