Abiomed, Inc. is a leading medical device manufacturer specializing in innovative cardiovascular and surgical solutions. Their products include a wide range of devices for cardiac and vascular procedures.
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, Inc. is a medical device company that focuses on cardiovascular and surgical technologies. They develop and manufacture devices for cardiac and vascular procedures.
Low risk due to regulatory compliance and quality assurance processes
Patients, healthcare providers, and medical facilities using Abiomed, Inc.'s products
Check for regulatory approvals (FDA, CE marking), product specifications, and safety data sheets
Ensure the product has FDA approval or equivalent CE marking for the target market
Check the technical documentation for proper usage and safety parameters
Review the safety data sheets for potential hazards and handling instructions
Yes, Abiomed, Inc. is a well-established medical device manufacturer with a strong reputation in the cardiovascular and surgical device market.
Abiomed, Inc. manufactures cardiovascular and surgical devices, including products for cardiac and vascular procedures.
Ensure the product has regulatory approvals (FDA, CE marking), review product specifications, and consult safety data sheets for detailed safety information.
We’ve drafted a message you can send Abiomed, Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-2955-2024 — Abiomed, Inc. Abiomed, Inc. Hello, I own a Abiomed, Inc. that is covered by recall Z-2955-2024 from Abiomed, Inc.. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
