Summary
The FDA issued a Class II for Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 by Abiomed, Inc.. Reason: 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 artic.
Details
Source
Device Recall
External ID
Z-2128-2023
Action Date
2023-07-19
Status
Ongoing
Category
device
Product Description
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Lot/Code Info: UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590
Quantity Affected: 37 units
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of MN, NJ, TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-26
Company
Danvers, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abiomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abiomed, Inc. have FDA actions?
Abiomed, Inc. has 66 FDA actions in our database, including 61 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2128-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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