Device product
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Z-2128-2023
Product summary
- Firm
- Abiomed, Inc.
- Event
- Event 92521
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 37 units
- Official record key
device-enforcement:Z-2128-2023
Official wording
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 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.
Code information: UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590
Distribution pattern: US Nationwide distribution in the states of MN, NJ, TN.
Derived failure modes
-
Unknown
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.