Recall Z-2128-2023— Abiomed, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abiomed, Inc., initiated 2023-05-26. It names one FDA 510(k) clearance: K222113. Product: Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457. 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..
- Recalling firm
- Abiomed, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-26
- Firm location
- Danvers, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.