Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. h

FDA device recall Z-2680-2026 · posted 2026-07-10 · Open, Classified

Recall details

Recalling firm

Oscor Inc.

Reason for recall

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.

Action taken

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 the information within this letter, complete all fields, sign, and return the attached business response form (BRF) (refer to Attachment 1) to Abiomed3958@sedgwick.com. 5. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). 6.If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. 7. Post a copy of this notice in a visible area for awareness.

Root cause

Device Design

Status

Open, Classified

Product code

DYB

Quantity affected

32,934 units

Distribution

Distribution in the US state of MA

Date initiated

2026-06-10

Date posted

2026-07-10

Location

Palm Harbor, FL

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