Recall Z-2128-2023 ยท DYB Introducer, Catheter
Abiomed, Inc.
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
| Date | Jul 11, 2023 (initiated May 26, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) notification letter was delivered to customers on 5/23/23. Customers were also contacted via telephone on 5/26/23. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal). DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your Abiomed local clinical field staff to coordinate the return of the subject products. 3. Review, complete all fields, sign, and return the attached Business Response Form (BRF) on the last page of this letter to the Recall Coordinator |
| Quantity | 37 units |
| Distribution | US Nationwide distribution in the states of MN, NJ, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222113 | Abiomed 14Fr Low Profile Introducer Set Abiomed, Inc., Oct 13, 2022 |