FDA Early Alert: Abiomed Recalls 14Fr Low-Profile Introducer Kits and Impella CP Sets Over Thrombus Risk

Key Summary

FDA's Center for Devices and Radiological Health (CDRH) has issued an early alert announcing Abiomed's voluntary recall of 14Fr low-profile introducer kits (product codes 1000434 and 1000435) and the associated Impella CP pump set (1000413). The recall is based on a higher-than-expected rate of thrombus formation during prolonged use, which has resulted in three serious injuries. Affected facilities should stop use immediately, quarantine inventory and return the products. The recall affects vascular access procedures for users of Impella CP Generation 10 and has implications for labeling, complaint handling and post-market surveillance.

Source and Applicability

Source agency: FDA CDRH News & Updates

Source page original publication date: July 16, 2026

Collection date: July 26, 2026, 07:34:42 UTC

Publication date: July 26, 2026, 15:48

Headline date referenced in the source: May 23, 2026

This article is compiled from public information published by FDA CDRH News & Updates. Source: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/catheter-introducer-kit-recall-abiomed-removes-14fr-low-profile-introducer-kits. Dates are reproduced as recorded in the source material. Specific requirements are subject to the latest official publication by the regulatory authority.

Full Translation of the Original Notice

CDRH Early Alert

CDRH is issuing this early alert to inform the public about a potentially high-risk device issue. FDA will continue to keep the public informed and will update this page as important new information becomes available.

Affected Products

FDA is aware that Abiomed has sent letters to affected customers recommending that all 14Fr low-profile introducer kits be removed from locations where they are used or sold.

Affected devices:

• Product code 1000542 — 14Fr x 13 cm and 25 cm low-profile introducer kits (Japan) — no UDI-DI listed
• Product code 1000434 — 14Fr x 13 cm low-profile introducer kit (for Impella CP) — UDI-DI 00813502012996
• Product code 1000435 — 14Fr x 25 cm low-profile introducer kit (for Impella CP) — UDI-DI 00813502013009
• Product code 1000413 — Impella CP with SmartAssist Set (Generation 10) — UDI-DI 00813502013566

Actions to Be Taken

Do not use the affected products. Check your inventory for affected introducer kits and quarantine any identified products for return.

On May 22, Abiomed sent letters to all affected customers recommending the following actions:

• Check inventory for affected introducer kits and quarantine any identified products
• Return affected products to Sedgwick
• Notify all personnel within your organization who manage, transport, store, stock or use these devices
• If any 14Fr low-profile introducer kits have been forwarded to another facility, contact that facility and provide it with the company notice
• Post a copy of the company notice in a prominent location for awareness

Reason for the Recall

Abiomed identified a higher-than-expected complaint rate for thrombus formation on the 14Fr low-profile introducer kit during prolonged use of the introducer. If thrombosis occurs, users may have difficulty aspirating the side arm or valve of the sheath. Users may also observe thrombus in the syringe or side arm, or around the valve, after aspiration or after removal of the CP pump.

During long-term support, thrombus formation within the lumen of the indwelling sheath, or in the annular gap between the inner diameter of the sheath and the outer diameter of the catheter, may interrupt blood flow near the access site. If thrombus dislodges during continued support, manipulation or removal, it may cause peripheral vascular occlusion with ischemia, requiring immediate clinical evaluation and intervention to restore perfusion. Less commonly, if uncorrected, the exposure may progress to irreversible vascular occlusion, potentially resulting in permanent injury.

The 14Fr low-profile introducer kits (product codes 1000434 and 1000435) are compatible only with Impella CP Generation 10 (product code 1000413); therefore, the pump set is also included in the scope of removal. This recall does not involve any other commercially available generation of Impella CP.

As of May 15, Abiomed had reported three serious injuries related to this issue. No deaths have been reported.

Device Use

The 14Fr low-profile introducer kit is intended to facilitate access to the vascular system for the introduction and removal of Impella CP with SmartAssist and accessory devices.

Contact Information

Customers in the United States who experience adverse reactions or quality problems, or who have questions about this recall, should contact Abiomed at OneMD-Field-Actions@its.jnj.com.

Additional FDA Resources

• FDA Enforcement Reports
• CDRH Medical Device Recall Database
• Unique Device Identification (UDI)

UDI helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. UDI enables more accurate reporting, review and analysis of adverse event reports, allowing faster identification of devices and the potential correction of problems.

• AccessGUDID Database — identify your medical device
• Benefits of the UDI system

How to report a problem: Healthcare professionals and consumers can report adverse reactions or quality problems experienced with the use of these devices through MedWatch: the FDA Safety Information and Adverse Event Reporting Program.

AIMEILI Regulatory Interpretation and Business Impact

What This Means for Medical Device Companies

Information of this kind published by FDA CDRH News & Updates should first be incorporated into a company's regulatory intelligence and post-market surveillance processes, rather than being read simply as general news. Companies need to determine whether the update is a guidance document, a recall safety communication, a product approval, a digital health item, a quality system item or post-market regulatory information, and to confirm whether it may affect existing registration projects or products under development.

Where the content concerns a specific product, test performance, risk signal or regulatory action, companies should further assess whether it affects product classification, the 510(k), De Novo or PMA pathway, technical documentation, labeling and instructions for use, quality system records or post-market reporting obligations. Companies pursuing US market registration should record the source link, publication date, scope of application and internal conclusions in the project file.

What Documentation Companies Should Review

Companies are advised to review the basis for product classification, applicable regulatory provisions, predicate device or substantial equivalence determinations, performance testing, software and cybersecurity documentation, risk management, clinical evidence, labeling and instructions for use, and quality system readiness.

Common Risks

Common risks include misjudging the FDA pathway, overlooking changes in guidance documents, insufficiently designed performance testing, overly broad labeling claims, unclear post-market reporting obligations, and applying documentation from other markets directly to US registration.

AIMEILI's View

This voluntary recall by Abiomed of 14Fr low-profile introducer kits and the compatible Impella CP pump sets carries significant warning value for companies engaged in the import and registration of cardiovascular interventional devices.

First, registration pathway. If comparable products have already been approved through the FDA 510(k) or PMA routes, companies should immediately verify whether their products are affected by this recall. For companies currently applying for FDA registration, or already approved for Impella CP-compatible accessories, FDA's new assessment conclusions on thrombus risk should be monitored closely; additional clinical data or updated risk management reports may be required.

Second, technical documentation should be re-examined. The recall was triggered by an abnormal rate of thrombus formation during prolonged use, which indicates that when preparing technical documentation for hemostatic valves, introducer sheaths and similar products, companies should strengthen biocompatibility evaluation and simulated-use testing addressing thrombus formation risk. For percutaneous ventricular assist devices similar to Impella, particular attention should be paid to design verification of the clearance between the sheath and the pump body, as well as long-term effectiveness data for antithrombotic coatings.

Third, labeling and instructions for use may need to be updated. In its alert, FDA emphasized that the product is intended for use only with a specific generation of Impella CP and that the risk increases significantly with extended use. Companies should check whether product labels clearly state compatibility limitations and the recommended duration of use. Where a similar low-profile design exists, instructions for use should add methods for early identification and management of thrombus formation, so that incomplete labeling does not create post-market compliance problems.

Fourth, for comparable imported products that have obtained NMPA registration, the local agent should initiate post-market surveillance. Companies are advised to check the FDA UDI-DI list immediately and confirm whether the scope of the corresponding Chinese registration certificate includes the affected models. If it does, the matter should be reported proactively to the National Medical Products Administration and coordinated with Abiomed's global recall. Distributors should quarantine inventory and establish traceability mechanisms.

Finally, this event again highlights the critical role of UDI in recall management. China's implementation of unique device identification is progressing, and companies should use this as an opportunity to improve internal data systems so that accurate identification and rapid response can be achieved throughout the product lifecycle. For companies planning to export to the United States, UDI codes must be correctly entered into the GUDID database, and FDA Enforcement Reports should be reviewed periodically to identify potential risks early.

Implications for International Registration Practice

From the perspective of international medical device registration practice, information published by FDA CDRH News & Updates should not be read merely as general news. Companies must first determine whether it concerns regulatory policy, guidance and standards, product approval, recall safety, quality systems or post-market regulatory information, because each type corresponds to different internal actions. Where a company is progressing a registration project in the relevant market, the update should be entered into the target-market regulatory tracking table, and the company should confirm whether it affects product classification, registration pathway, applicant entity, local agent responsibilities or certificate maintenance arrangements.

For Chinese medical device companies, the direct impact of this FDA early alert on Abiomed's 14Fr low-profile introducer kits is typically reflected in documentation consistency and evidence chain management. Companies should check existing technical files, risk management reports, performance verification data, clinical evaluation or clinical evidence, labeling and instructions for use, quality system certificates and post-market surveillance documentation to confirm that these materials still support the latest regulatory expectations of the target market. Where the information concerns a safety notice, recall, product approval or regulatory meeting, companies should also assess whether similar products, similar technology routes or similar risk points may receive heightened attention from reviewers.

At the operational level, AIMEILI recommends three actions. First, record the official source link, publication date, scope of affected products and potentially affected areas in the regulatory tracking log. Second, have regulatory, quality, R&D and sales functions jointly determine whether labels, instructions for use, clinical evaluation, risk management or test reports need to be updated. Third, if the company has already marketed products locally or has submitted a registration application, it should assess in parallel whether the local agent, importer, distributor and after-sales team need to take communication, change, supplementary explanation or post-market surveillance measures.

The value of this type of news lies not simply in knowing what a regulator has published, but in converting public information into executable compliance actions. For companies preparing for multi-country registration, particular attention should be paid to the boundaries of documentation reuse across markets: the same set of CE, FDA, NMPA, ISO 13485 or MDSAP documentation may serve as core evidence in one country while requiring localized explanations, translated labels, authorized representative documents or post-market maintenance plans in another. AIMEILI recommends that companies conduct a brief documentation gap review after each significant regulatory update, so as to avoid difficulties at later deficiency response, change or certificate renewal stages.

FAQ

Does an update to an FDA public page always represent a regulatory change?

No. An update to an FDA public page does not by itself constitute a regulatory change; it may be a news item, guidance, database entry, recall information or a formal regulatory document, and material content should be verified against the original FDA text and the applicable regulations.

Companies should therefore classify the nature of the update before deciding whether any internal action is required.

What should companies do after seeing an FDA update?

Companies should first determine whether the update affects product classification, registration pathway, technical documentation or post-market obligations, and then decide whether to update the project plan.

Where an impact is identified, the assessment and the resulting decisions should be documented in the regulatory tracking file and, where relevant, reflected in labeling, risk management, clinical evaluation or post-market surveillance activities.

Content Review and Scope of Application

Author: AIMEILI Regulatory Editorial Team

Professional review: AIMEILI International Medical Device Registration Project Team

Source principles: Priority is given to official regulatory authorities, international organizations, standards bodies and publicly available regulatory materials; industry media and project experience are used only as supporting references.

Scope of application: This article is intended for preliminary understanding, documentation preparation and project planning. It does not replace the formal requirements of the regulatory authority in the target country, testing conclusions or legal advice.