Z-0586-2018Class I

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria...

Name: Z-0586-2018 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria...
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2017-12-19
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-12-19 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI... on 2017-12-19. FDA classified it as Class I and gives the reason as "Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D)". 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-0586-2018
Classification: Class I
Status: Terminated
Initiated: 2017-12-19
Posted: 2018-02-01
Terminated: 2021-08-27
Recalling firm: Medtronic, Inc.
Product: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria MRI Quad CRT-D DF1 (Product No. DTMA1Q1) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 12/19/2017, Medtronic verbally notified consignees and retrieved eight devices at sites that had affected inventory on hand. On 01/22/2018, Medtronic provided a recall notification letter to physicians following 48 patients implanted with affected devices and risk managers of those medical facilities, recommending that physicians strongly consider prophylactic device replacement for patients implanted with an affected device. Medtronic Technical Services is available to assist physicians with questions at 800-723-4636. Medtronic Patient Service is available to assist patients at 800-551-5544 (Monday-Friday, 8am-5pm Central Time). The recall was expanded on 03/15/2018 and customers were notified by letter. Affected product, not yet implanted, was retrieved on about 03/08/2018. Instructions in the physicians following patients implanted with the additional affected devices included prophylactic device replacement for those patients at higher risk, including patients whose clinical history indicates prior need for high-voltage therapy and/or for pacemaker-dependent patients. The physicians should carefully weigh the risks and benefits of device replacement. If it is determined that replacement is not warranted, instructions included the following: programming changes to reduce the potential for high-voltage charges associated with arrhythmia detection and therapies, such as enabling ATP before charging for fast ventricular rhythms or programming a separate fast VT via VF zone with ATP; Continue three-month in-clinic or remote follow-ups to verify device functionality because inability to interrogate a device or a failed remote monitoring transmission may be an indication that internal arcing has occurred; and to advice patients to seek medical attention immediately if they experience new or unexpected symptoms suspicious for a ventricular arrhythmia. Medtronic Patient Services is available to assist patients at 800-551-5544 (Monday-Friday, 8am-5pm Centra
Quantity in commerce: 951 devices total
Distribution: US Nationwide Distribution.
Product codes and lots: a. Product No. DTMA1D1: UDI 00643169705777 (Serial No. RPT200245H) (EXPANSION Serial No. RPT201653H, RPT200308H, RPT201033H, RPT202625H, RPT201913H, RPT202623H, RPT202624H, RPT202627H, RPT202626H), 00643169929531 (Serial No. RPT202182H); b. Product No. DTMA1QQ: UDI 00643169543362 (Serial No. RPA202057H) (EXPANSION: Serial No. RPA200224H, RPA200472H, RPA200673H, RPA201732H, RPA201733H, RPA202258H, RPA202454H, RPA202455H, RPA202649H, RPA202650H, RPA202651H, RPA202652H, RPA202653H, RPA203381H, RPA203416H, RPA203546H, RPA203547H, RPA204428H, RPA204605H, RPA204606H, RPA201333H, RPA202259H), 00643169929562 (Serial No. RPA204495H); EXPANSION: c. Product No. DTMA1D4: UDI 00643169543416 (Serial No. RPC200266H, RPC200772H, RPC200830H, RPC201028H, RPC201030H, RPC201382H, RPC201056H, RPC201383H); d. Product No. DTMA1Q1: UDI 00643169705760 (Serial No. RPS200939H)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0586-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0582-2018	Class I	Terminated	Voluntary: Firm initiated	2018-02-28	2018-04-19
Z-0583-2018	Class I	Terminated	Voluntary: Firm initiated	2018-02-28	2018-04-19
Z-0584-2018	Class I	Terminated	Voluntary: Firm initiated	2018-02-28	2018-04-19
Z-0585-2018	Class I	Terminated	Voluntary: Firm initiated	2018-02-28	2018-04-19
Z-0586-2018	Class I	Terminated	Voluntary: Firm initiated	2018-02-28	2018-04-19
Z-0587-2018	Class I	Terminated	Voluntary: Firm initiated	2018-02-28	2018-04-19
Z-0588-2018	Class I	Terminated	Voluntary: Firm initiated	2018-02-28	2018-04-19
Z-0589-2018	Class I	Terminated	Voluntary: Firm initiated	2018-02-28	2018-04-19

Product code NIK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)