Medtronic Medical Device Identification Card for SureScan pacemaker… — Class II medical device recall Z-0022-2016
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2015-10-14, distributed nationwide. Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete
| Recall number | Z-0022-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2015-09-15 |
| Classified | 2015-10-05 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2016-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 777 cards |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0022-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.