Abiomed, Inc. 2024-09-11 Health serious FDA
Health · FDA · Recall #FDA-Z-2967-2024
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; Recall
Issued September 11, 2024 · Abiomed, Inc.
In September 2024, Abiomed, Inc. recalled the ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
What you should do
- 1 Stop using ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Abiomed, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Abiomed, Inc.
- Category
- Health
- Recall date
- September 11, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck R
- Recall number
- FDA-Z-2967-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Abiomed, Inc. has 9 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.