Z-0282-2022Class II

Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic...

Name: Z-0282-2022 Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic...
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2021-10-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-10-12 / Open, Classified / root cause: software

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter... on 2021-10-12. FDA classified it as Class II and gives the reason as "The processing of collected episode data may fail due to a software error". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0282-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-12
Posted: 2021-11-24
Recalling firm: Medtronic, Inc.
Product: Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DPA2D4; Cobalt DR: DDPB3D1, DDPB3D4; Cobalt XT HF: DTPA2D4, DTPA2D1; Cobalt XT HF; Quad: DTPA2QQ, DTPA2Q1; Cobalt HF: DTPB2D4, DTPB2D1; Cobalt HF Quad: DTPB2QQ, DTPB2Q1. Crome VR: DVPC3D1, DVPC3D4; Crome DR: DDPC3D1, DDPC3D4; Crome HF: DTPC2D4, DTPC2D1; Crome HF Quad: DTPC2QQ, DTPC2Q1.
Product code: OSR Pacemaker/Icd/Crt Non-Implanted Components
Reason for recall: The processing of collected episode data may fail due to a software error.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm began issuing the correction notification dated October 2021 on 10/12/2021 via 2-day UPS delivery that was addressed to risk managers or clinical managers. The letter recommends physicians follow normal clinical practices given the implanted Cobalt/Crome devices will continue to operate as programmed. If a failure to interrogate a Cobalt or Crome device occurs with a SmartSync programmer, the physician is to confirm that the SmartSync application software has been updated to D00U005 version 5.0.0 (or higher). They are to contact their Medtronic representative or Tachy Technical Services at 800-723-4636 for assistance with retrieving the session data. If a CareLink transmission is attempted, but the transmission is not viewable on the CareLink network (i.e., the transmission is missing from the transmission list for the patient), the physician is to contact Medtronic Technical Services at 800-723-4636 for assistance. The notice is to be shared with those who need to be aware within the consignee's organization or with any organization where the SmartSync programmers may have been transferred. Consignees are asked to sign and return the enclosed confirmation form and confirm that the SmartSync tablets have been updated to Cobalt/Crome application software D00U005, version 5.0.0 or higher.
Quantity in commerce: 18,715 devices
Distribution: Worldwide distribution - US Nationwide. There was military/government distribution. The countries of Andorra, Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Liechtenstein, Luxembourg, Martinique, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Product codes and lots: Application software lower than v5.0.0.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0282-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0282-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-24

Product code OSR

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