Z-0022-2016Class II

Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card...

Name: Z-0022-2016 Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card...
Creator: Medtronic Inc. Cardiac Rhythm Disease Management
Published: 2015-09-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-09-15 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. Cardiac Rhythm Disease Management began a recall of Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components... on 2015-09-15. FDA classified it as Class II and gives the reason 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0022-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-15
Posted: 2015-10-05
Terminated: 2016-04-14
Recalling firm: Medtronic, Inc.
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.
Product code: DTB Permanent Pacemaker Electrode
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On September 15, 2015, Medtronic began mailing an Important Medical Device Identification Card Notification letter, including a corrected Medical Device Identification Card, to impacted patients. The letter described the issue, provided a new corrected Identification Card, asked that the old card be destroyed immediately, and to begin using the new card. Patients can contact Medtronic Patient Services at 1-800-551-5544, option 1, followed by option 3, Monday - Friday, 8am - 5pm Central time.
Quantity in commerce: 777 cards
Distribution: US nationwide distribution.
Product codes and lots: no codes on the cards

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0022-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0022-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-05

Product code DTB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)