Recall Z-0895-2022 ยท DQY Catheter, Percutaneous
Abbott
Amplatzer Steerable Delivery Sheath
| Date | Nov 9, 2021 |
| Status | Terminated |
| Reason | Instructions for use were updated. |
| Root cause | Device Design |
| Action | Impacted consignees will receive a notification letter via registered mail, from an Abbott field representative, or via phone call and a follow-up email where in-person communication is not possible. The product is not being removed from the field and does not need to be returned. The recalling firm is providing additional instructions to reduce the potential for air ingress. |
| Quantity | 529 units |
| Distribution | OUS distribution only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212026 | Amplatzer Steerable Delivery Sheath ABBOTT MEDICAL, Sep 27, 2021 |