Abiomed is a leading manufacturer of medical devices, specializing in cardiovascular and surgical equipment. Their products include heart valves, catheters, and other critical medical tools.
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.
Abiomed is a company that produces medical devices, particularly focusing on cardiovascular and surgical equipment. They are known for their heart valves and catheters.
Low risk of harm from medical devices. The devices are designed to be safe and effective for their intended use.
Patients, healthcare professionals
Check for proper certification and regulatory compliance (e.g., FDA approval) before use.
Ensure the device is certified by the relevant regulatory authority (e.g., FDA in the US).
Follow the manufacturer's instructions for use and maintenance.
Abiomed produces medical devices such as heart valves, catheters, and other cardiovascular and surgical equipment.
Yes, Abiomed devices are designed to be safe and effective for their intended use, but always check for proper certification and regulatory compliance.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2965-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2965-2024 from Abiomed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
