Abiomed recalls 14Fr Low Profile Introducer Set (Product #1000457) due to potential sidearm detachment during pump explant from silicone oil contamination.
There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.
Abiomed is recalling its 14Fr Low Profile Introdu: 14Fr Low Profile Introducer Set (Product #1000457) because a silicone oil contaminant may cause the sidearm to detach during pump explant. This could lead to complications during medical procedures.
The device may detach during pump explant due to a silicone oil contaminant that forms at the joint between the sidearm and hub when exposed to heat, humidity, or movement. This contamination occurs during manufacturing and can cause the sidearm to separate from the hub.
Patients using this device for heart pump procedures are most at risk. Healthcare providers who use the device for implantation or explant are also affected.
Check for Product Number 1000457 on the device. Lot Numbers 1727033 and 1725590 are also associated with this recall.
Verify the product number (1000457) and lot numbers (1727033, 1725590) on the device.
Yes, there was one complaint that the sidearm detached during pump explant due to a silicone oil contaminant that may cause joint detachment.
Check for Product Number 1000457 and Lot Numbers 1727033 or 1725590 on the device.
The recall does not specify a remedy, so contact Abiomed directly for guidance.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2128-2023 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-2128-2023 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.
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.
