Use cautionMedical device recall · FDA · Published May 26, 2023
Abiomed 14Fr Low Profile Introducer Set Recall: Sidearm Detachment Risk
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.
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Contact the company
📍Recalling firmAbiomed, Inc.24 Cherry Hill Dr · Danvers, MA 01923-2575
“Abiomed 14Fr Low Profile Introducer Set Recall: Sidearm Detachment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57949-abiomed-14fr-low-profile-introducer-set-recall-sidearm-detachment-risk. Based on FDA recall #Z-2128-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2128-2023%22&limit=1).
The FDA announced on May 26, 2023, that Abiomed, Inc. is voluntarily recalling the Abiomed 14Fr Low Profile Introducer Set due to a hazard where the sidearm may detach during use. This Class II recall affects 37 units distributed in Minnesota, New Jersey, and Tennessee.
How to tell if you have it
Brand: Abiomed
Product: Abiomed 14Fr Low Profile Introducer Set
Product Number: 1000457
UDI-DI: 00813502013252
Lot Numbers: 1727033, 1725590
The hazard
According to the FDA, one complaint reported that the sidearm of the device detached during explant of a pump. The hazard occurs when sidearms are subjected to heat, humidity, and articulation, causing a silicone oil contaminant at the joint between the sidearm and hub to detach the joint.
Context
GovInfoNow's records show Abiomed, Inc. has had 28 other recalls on record since September 4, 2019. Recent brand recalls include the Abiomed Impella Controller purge cassette recognition issues (August 12, 2026), the Abiomed Impella CP Smart Assist Set introducer sheath leakage risk (June 11, 2026), and the Abiomed Impella CP set blood clot risk (May 22, 2026). Other recent recalls of similar products include the Oscor Abiomed Introducer Kit potential sheath leakage risk (June 10, 2026), the Oscor Abiomed Introducer Kit potential leaks in 14F sheaths (June 10, 2026), and the Medtronic MiniMed 640G Insulin Pump incorrect insulin delivery risk (July 13, 2026).
How to tell if you have this one
Check for Product Number 1000457 on the device. Lot Numbers 1727033 and 1725590 are also associated with this recall.
Brand
Abiomed
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify the product number (1000457) and lot numbers (1727033, 1725590) on the device.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of MN, NJ, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Minnesota, New Jersey, Tennessee.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2128-2023 (May 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2128-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.