Urgent site urgencyFDA Class I

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

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.

Agency: FDA Device
Recall date: Jun 10, 2026
Status: Ongoing
Company: Oscor Inc.

1. What product was recalled?

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

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

Quantity: 32,934 units

Code or lot text: All Lots within Expiry/GTIN:00885672009755/00813502011609

LOT: All Lots within Expiry/GTIN:00885672009755/00813502011609
RECALL-NUMBER: Z-2680-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

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.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Massachusetts

View source evidence for state distribution

Massachusetts: Distribution in the US state of MA

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked 10/1/2026, 7:00:04 PM UTC.

2026-10-01T19:00:04.000Zupdated
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10. Where is the official source?

Open the official FDA Device source

The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.