Recall Z-0282-2022 ยท OSR Pacemaker/Icd/Crt Non-Implanted Components
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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
| Date | Oct 12, 2021 |
| Status | Open, Classified |
| Reason | The processing of collected episode data may fail due to a software error. |
| 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 Tec |
| Quantity | 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, Irela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.