Company · Danvers, MA, United States
Abiomed Inc.
Everything this company holds in Health Canada’s product databases, as the company’s name is spelled there.
- Drug products (DIN)
- 0
- 0 authorized now
- Natural health products
- 0
- 0 active licences
- Medical device licences
- 4
- 2 active
- Notices of Compliance
- 0
Medical device licences
Active licences first, newest first.
| Name | Licence | Status | First licensed |
|---|---|---|---|
| IMPELLA RP CIRCULATORY SUPPORT SYSTEMFirst licensed Mar 2017 | 98766 | Issued (active) · Class 4 | |
| IMPELLA CIRCULATORY SUPPORT SYSTEMFirst licensed Jun 2007 | 74175 | Issued (active) · Class 4 | |
| AB5000 CIRCULATORY SUPPORT SYSTEMFirst licensed Oct 2005 | 69475 | Discontinued at renewal · Class 4 | |
| BVS 5000 BI-VENTRICULAR SUPPORT SYSTEMFirst licensed Dec 2002 | 61089 | Discontinued at renewal · Class 4 |
Recalls and safety alerts that mention its products
Health Canada’s recall notices do not carry licence numbers, so these are matched by name. A notice may cover another product or only some lots: read it to see what it covers.
- Automated Impella® Controllers (AIC)October 2, 2026 · Cardiovascular · Performance · Type I
- Automated Impella Controller (AIC)August 27, 2026 · Cardiovascular · Performance · Type II
- Abiomed Introducer Kits with Impella Heart PumpsJune 29, 2026 · Cardiovascular · Performance · Type I
- Impella ControllerMay 13, 2026 · Cardiovascular · Performance · Type I
- Automated Impella® ControllerApril 28, 2026 · Cardiovascular · Performance · Type I
- Abiomed Purge Cassette Generation 1 for ImpellaMarch 4, 2026 · General hospital and personal use - Cardiovascular · Performance · Type I
- Automated Impella ControllerFebruary 25, 2026 · Cardiovascular · Performance · Type I
- Automated Impella® ControllerOctober 23, 2025 · Cardiovascular · Performance · Type II
- Impella ControllerSeptember 18, 2025 · Cardiovascular · Performance · Type I
- Impella® ControllerAugust 29, 2025 · Cardiovascular · Performance · Type I
- Impella® ControllerJuly 9, 2025 · Cardiovascular · Performance · Type I
- Impella CP With SmartAssist and Impella 5.5 With SmartAssistSeptember 5, 2024 · Cardiovascular · Device compatibility · Type I
- Impella CpMarch 20, 2024 · Cardiovascular · Device compatibility · Type I
- Impella ProductsMarch 12, 2024 · Cardiovascular · Labelling and packaging · Type II
- Impella SystemsMarch 6, 2024 · Cardiovascular · Labelling and packaging · Type I
- Introducer kits in Impella Pump Set and Axillary Insertion KitDecember 21, 2023 · Cardiovascular · Labelling and packaging · Type II