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.
- Recall Initiated
- October 12, 2021
- Recall Number
- Z-0282-2022
- Quantity
- 18,715 devices
- Firm Location
- Mounds View, MN
Reason for Recall
The processing of collected episode data may fail due to a software error.
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.
Lot / Code Info
Application software lower than v5.0.0.
Root Cause
Software design
Action Taken
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.