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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic CareLink SmartSync

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  Class 2 Device Recall Medtronic CareLink SmartSync see related information
Date Initiated by Firm October 12, 2021
Create Date November 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-0282-2022
Recall Event ID 88907
PMA Number P010031S750 
Product Classification Pacemaker/icd/crt non-implanted components - Product Code OSR
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.
Code Information Application software lower than v5.0.0.
Recalling Firm/
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact
800-723-4636
Manufacturer Reason
for Recall
The processing of collected episode data may fail due to a software error.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = OSR and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
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