Recall Z-2679-2026 ยท DYB Introducer, Catheter
Oscor Inc.
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
| Date | Jul 10, 2026 (initiated Jun 10, 2026) |
| Status | Open, Classified |
| Reason | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. |
| Root cause | Device Design |
| Action | On June 10, 2026, Oscor (an Integer subsidiary ) issued a Urgent Medical Device Recall notification to affected consignees. Oscor asked consignees to take the following actions: 1. Product removal is not required, and hospitals may continue to use existing inventory. 2. Physicians should continue to use appropriate clinical awareness, monitoring, and patient support as needed. 3. Consider a device exchange or using the repositioning sheath to minimize blood loss if potential leakage from the sidearm and under the sheath cap and along the hub score lines in the hub region is observed. 4.Review |
| Quantity | 1332 units |
| Distribution | Distribution in the US state of MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES Oscor, Inc., Aug 29, 2012 |