—#189977

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.

FDA product code: OSR — Pacemaker/Icd/Crt Non-Implanted Components
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P010031S750
Affected lot / code info: Application software lower than v5.0.0.

Why it was recalled

The processing of collected episode data may fail due to a software error.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-10-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189977. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.