Recall Z-0022-2016— Medtronic Inc. Cardiac Rhythm Disease Management

Name: FDA recall Z-0022-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-15

Class II · Terminated

Class II FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2015-09-15, terminated 2016-04-14. It names 3 FDA 510(k) clearances: K940703, K932172, K883743. 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..

Recalling firm: Medtronic Inc. Cardiac Rhythm Disease Management
Classification: Class II
Status: Terminated
Initiated: 2015-09-15
Terminated: 2016-04-14
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

3 on FDA's record

K940703 — MEDTRONIC MODEL 4558MMedtronic Vascular·cleared 1994-11-04
K932172 — MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADSMedtronic Vascular·cleared 1993-12-08
K883743 — MEDTRONIC MODEL 4058 PACING LEADMedtronic Vascular·cleared 1989-01-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.