Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f

FDA device recall Z-0946-2021 · posted 2021-02-04 · Open, Classified

Recall details

Recalling firm

Heartware, Inc.

Reason for recall

Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.

Action taken

On 11/19/2020, notifications initiated to inform about recall. Additional notifications sent on 5/18/2022 (https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-urgent-medical-device-notice-update-june-2022.pdf), 10/13/2022 and May 08, 2024. On 8/20/2025, communications initiated to inform about algorithm C controller that will attempt to pump restart using algorithm A, and if needed algorithm B. It will mitigate controller resetting. Blue line highlights on algorithm C controller exterior differentiates it from previous versions. Healthcare providers asked to speak with patients. Issue does not cause a running pump to stop; rather, a failure to restart may follow a pump stop event. A controller AC adapter should be attached to any controller being used to restart a stopped pump, which will provide consistent power for restart attempts. If unavailable, connect two fully or partially charged batteries to the controller as soon as possible during any pump restart attempt. Reinforce patient manual and instructions for use: -Do NOT disconnect the driveline from controller. - ALWAYS ensure two power sources are connected to controller. - NEVER disconnect both power sources (batteries and AC or DC adapter) from controller at the same time; one external power source should remain connected to controller at all times. - Do NOT exchange controller unless explicitly directed by a high priority alarm condition or a VAD team member. - Reinforce the proper response to a Controller Fault alarm and Electrical Fault alarm. These are medium priority alarms unrelated to an immediate pump stop. These alarms will result in the word Call in the controller display, notifying the patient to call their clinician. - Reinforce making good connections of power sources and the data cable in the controller ports. Complete and return response form via email to rs.cfqfca@medtronic.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DSQ

Quantity affected

19,562 units

Distribution

Worldwide - US Nationwide

Date initiated

2020-11-19

Date posted

2021-02-04

Location

Miami Lakes, FL