Z-2128-2023 Class II Ongoing
FDA device recall Z-2128-2023 was initiated by Abiomed, Inc. on May 26, 2023 and is designated Class II. 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 unint… The recall status is ongoing. Affected quantity: 37 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2023
- Initiation Date
- May 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37 units
Product Description
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
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 Pattern
US Nationwide distribution in the states of MN, NJ, TN.
Code Information
UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590