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Recall Observatory FDA recall evidence

Device product

Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

Z-2128-2023

May 26, 2023

Class II

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

    reason.no_named_rule · v1.0.0

    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.