Lower risk Medical device recall · FDA · Published June 11, 2026

Abiomed Impella CP Set Recall: Introducer Sheath Leakage Risk

Abiomed recalls Impella CP Set (Code 0048-0003) due to potential introducer sheath leakage. This risk may cause complications during heart pump procedures. Affected units include specific model sizes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2682-2026Medical device Abiomed ›

Lower-risk recall

A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.

Take action

Contact the company

Recalling firmAbiomed, Inc.22 Cherry Hill Dr · Danvers, MA 01923-2575

✎ GovInfoNow plain-language explainer

Abiomed is recalling its Impella CP Set (Pump Set Code 0048-0003) because manufacturing issues could cause sheath leakage in the introducer. This leakage might lead to complications during heart pump procedures, though it's not immediately dangerous. Read more at govinfonow.com/recall/49005-abiomed-impella-cp-set-recall-introducer-sheath-leakage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/49005-abiomed-impella-cp-set-recall-introducer-sheath-leakage-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2682-2026

Cite this page

“Abiomed Impella CP Set Recall: Introducer Sheath Leakage Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49005-abiomed-impella-cp-set-recall-introducer-sheath-leakage-risk. Based on FDA recall #Z-2682-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2682-2026%22&limit=1).

The FDA announced on June 11, 2026, that Abiomed, Inc. is recalling ABIOMED Impella CP Sets containing BIOMED Impella Introducers due to potential sheath leakage. The agency classified the recall as Class I.

How to tell if you have it

ABIOMED Impella CP Set, Pump Set Code 0048-0003
BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046
UPC 00813502011876
UPC 00813502012279

The hazard

According to the FDA, a potential for introducer sheath leakage exists from under the sheath cap and along the hub score lines. These manufacturing issues are not visually detectable by the user.

Context

GovInfoNow's records show Abiomed, Inc. has 28 other recalls on record since September 4, 2019. Other recent recalls of similar products include Abiomed Impella Optical Controller Recall (August 12, 2026), Abiomed Impella CP Set with SmartAssist: Risk of Blood Clots During Prolonged Use (May 22, 2026), and Abiomed Impella CP Set with SmartAssist Recall: Low Purge Pressure Alarms (May 18, 2026). Other recent recalls of similar products include Oscor Abiomed Introducer Kit Recall (June 10, 2026).

How to tell if you have this one

Check for the pump set code 0048-0003 or introducer product code 0052-3046. The affected units include 14Fr (13 cm and 25 cm) introducers.

Brand
Abiomed
Product
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product
Category
Medical device

FDA recall event · 13 products

All 13 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (JP), Kuwait (KW), Luxembourg (LU), Malaysia (MY), Mexico (MX), Netherlands (NL), Norway (NO), Panama (PA), Poland (PL), Saudi Arabia (SA), Serbia (RS), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), United Arab Emirates (AE), and United Kingdom (GB).

Recall number	Product, codes & lots	Quantity
Z-2681-2026	ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories; Pump Set Code 1000323; introducer Product Code 2000342. GTIN 00813502012811. All current batches in field.	5,017 units
Z-2682-2026	ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories; Pump Set Code 0048-0003; Introducer Product Code 0052-3046. GTIN: 00813502012279, 00813502011876. All current batches in field.	87,277 units
Z-2683-2026	ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories; Pump Set Code 1000550; Introducer Product Code 0052-3046. GTIN: 00813502013474. All current batches in field.	846 units
Z-2684-2026	ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories; Pump Set Code 1000441; Introducer Product Code 2000342. GTIN: 00813502012910. All current batches in field.	196 units
Z-2685-2026	ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories; Pump Set Code 0052-0038; Introducer Product Code 0052-3052. GTIN: 00813502011708, 00813502012729. All current batches in field.	1,540 units
Z-2686-2026	ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories; Pump Set Code 0052-0039; Introducer Product Code 0052-3053. GTIN: 00813502011715, 00813502012736. All current batches in field.	1,223 units
Z-2687-2026	ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories; Pump Set Codes 1000211, 1000212; Introducer Product Code 0052-3006-JP. GTIN: 00813502012453. All current batches in field.	383 units
Z-2688-2026	ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories; Pump Set Codes 1000459, 1000460; Introducer Product Code 0052-3006-JP. GTIN: 00813502013054. All current batches in field.	1,574 units
Z-2689-2026	ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories; Pump Set Code 0048-0014; Introducer Product Code 0052-3046. GTIN: 00813502012873, 00813502013344, 00813502013368, 04260113630280. All current batches in field.	35,430 units
Z-2690-2026	ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories; Pump Set Code 0048-0024-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011609. All current batches in field.	8,382 units
Z-2691-2026	ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories; Pump Set Code 0048-0044; Introducer Product Code 0052-3046. GTIN: 00813502012200. All current batches in field.	557 units
Z-2692-2026	ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories; Pump Set Code 0052-0011-JP; Introducer Product Code 0052-3006-JP. GTIN: 00813502011340. All current batches in field.	117 units
Z-2693-2026	ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories; Pump Set Code 0052-0023-JP; Introducer Product Code 0052-3025-JP. GTIN: 00813502011449. All current batches in field.	96 units

Based on the official FDA remedy

What to do — step by step

Check Product Codes
Look for pump set code 0048-0003 or introducer product code 0052-3046 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 4 states.

FDA distribution: “Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR),…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Delaware, Illinois, Pennsylvania.

Recall timeline

FDA published this recall 41 days after the firm started it.

Jun 11, 2026Firm started the recall
Jul 10, 2026FDA classified it Class I
Jul 22, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/49005-abiomed-impella-cp-set-recall-introducer-sheath-leakage-risk">Abiomed Impella CP Set Recall: Introducer Sheath Leakage Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2682-2026 (June 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2682-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.