FDA Device recall Z-0022-2016
Medtronic Medical Device Identification Card for SureScan pacemaker patients
- FDA Device
- Class II
- terminated
- Published 2015-10-14
On 2015-10-14 the FDA classified a Class II recall of Medtronic Medical Device Identification Card for SureScan pacemaker patients by Medtronic Cardiac Rhythm Disease Management, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0022-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-15 |
| Published | 2015-10-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Cardiac Rhythm Disease Management |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | no codes on the cards |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0022-2016%22
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