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Introducer Kit for Impella recallZ-2680-2026 · Oscor Inc. · initiated Jun 10, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Oscor Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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 [email protected]. 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.

Recall details

Recall number
Z-2680-2026
Status
Open, Classified
Initiated by the company
Jun 10, 2026
Posted by the FDA
Jul 10, 2026
Recalling firm
Oscor Inc.
Quantity
32,934 units
Product code
DYB
FDA submissions
K122084
Distribution
Distribution in the US state of MA

Product description

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

Code information (models, lots, serial numbers)

All Lots within Expiry/GTIN:00885672009755/00813502011609

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

29 devices cleared under K122084 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99102).

Sources and updates

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