Automated Impella Controller Recall
Recalls and safety alerts
By RecallRadar Editorial Team
Sourced from Health Canada. Last verified March 4, 2026.
On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- February 25, 2026
- Source agency
- Health Canada
This is a minor issue or quality improvement program.
✨ Plain-English Summary
The Automated Impella Controller medical device has been recalled due to a quality issue. Both healthcare providers and consumers may be affected by this recall. Check the official FDA notice for specific lot numbers and return or disposal instructions.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
What's Being Recalled
Full details from the recall report.
Recalls and safety alerts
Quick Info
Key facts from the official notice, kept in the article flow for easy cross-checking.
- Brand
- Abiomed inc.
- Category
- medical
- Source agency
- Health Canada
- Announced
- February 25, 2026
- Country
- CA
- Status
- Active
Who's Affected
Specific model or serial details were not published in this source snapshot. Check the official recall page with your exact model and serial number.
What You Should Do
Follow the remedy path from the official notice using the exact model and serial details above.
- 1Contact the manufacturer if you require additional information.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- Health Canada
- Announced by source
- February 25, 2026
- Last reviewed by RecallRadar
- March 4, 2026
Frequently Asked Questions
Am I affected by this recall?
Check the affected models section on this page. The official notice currently lists Abiomed Inc. products listed in the official notice.
What is the remedy for this recall?
Contact the manufacturer if you require additional information.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://recalls-rappels.canada.ca/en/alert-recall/automated-impella-controller
Keep browsing with these internal hubs: Abiomed Inc. recall hub and Medical recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
View official notice from Health CanadaSee an inaccuracy?
Help us improve the accuracy of this recall information.
On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- February 25, 2026
- Source agency
- Health Canada
Related Recalls
BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Jun 10, 2026
Atlan A350XL. Model Number: 8621600. anesthesia workstation
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Jun 10, 2026
BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Jun 10, 2026
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
Jun 10, 2026
BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Jun 10, 2026