FDA Device Recall Z-0022-2016: Medtronic Inc. Cardiac Rhythm Disease Management

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0022-2016.

Recall Res Number

Z-0022-2016

Recalling Firm / Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management

FEI Number

2182208

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2015-09-15

Date Posted

2015-10-05

Date Terminated

2016-04-14

Product Code

DTB

Event Number

72245

Product Quantity

777 cards

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.

Action Details 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.

Distribution Pattern US nationwide distribution.

Code Information / Serial Numbers no codes on the cards

Related Establishments / Registrations

BIOTRONIK, INC. Registration: 1028232 View Registration
OSCOR INC. Registration: 1035166 View Registration
INTERNATIONAL STERILIZATION LABORATORY, LLC Registration: 1061927 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
ABBOTT MEDICAL Registration: 2017865 View Registration
PRO-TECH DESIGN & MFG., INC. Registration: 2032521 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
MEDTRONIC, INC. Registration: 2182208 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
Greatbatch Medical Registration: 2183787 View Registration
Boston Scientific Corporation Registration: 2648729 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA Registration: 2649622 View Registration
Heraeus Medical Components Caribe, Inc. Registration: 3005029049 View Registration
Abbott Medical Registration: 3006705815 View Registration
Abbott Medical Registration: 3008494315 View Registration
Medtronic Singapore Operations Pte Ltd Registration: 3008973940 View Registration
HERAEUS MEDICAL COMPONENTS, LLC Registration: 3008988055 View Registration
Medtronic Distribution Center Registration: 3009380063 View Registration
ABBOTT MEDICAL Registration: 3013288201 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
BIOTRONIK SE & CO. KG Registration: 9610139 View Registration
Boston Scientific Limited Registration: 9616693 View Registration

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Medical Device Recall: Z-0022-2016

Recall Parameters & Description

Related Establishments / Registrations

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