Recall Z-1110-2022 ยท DSQ Ventricular (Assist) Bypass
Medtronic Inc
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00
| Date | Mar 30, 2022 |
| Status | Open, Classified |
| Reason | Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system. |
| Root cause | Labeling design |
| Action | Starting 30-Mar-2022, Medtronic issued an Urgent Medical Device Notice by letter to VAD Coordinators at customer sites in order to inform them of the errors and the corrections impacting the Instructions for Use, Patient Manual, and Emergency Responder Guide for the HVAD System. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients of the issues to the Patient Manual. Customer Instructions: "Please ensure your patients on support are aware of the changes to the PM. "Please share this notice with everyone |
| Quantity | 21,118 pieces of product literature |
| Distribution | Worldwide Distribution: US (nationwide) and OUS to countries of: Australia, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, INDIA, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.