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Open, Classified

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

FDA Recall Z-2682-2026 · Posted 2026-07-10

Recalling FirmAbiomed, Inc.
Recall StatusOpen, Classified
Product CodeDYB
Date Initiated2026-06-11
Product Quantity87,277 units

Reason for 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.

Firm Action

An URGENT MEDICAL DEVICE RECALL (CORRECTION) notice dated 06/10/2026 was mailed to consignees. The notice directs consignees to maintain awareness of this recall among practitioners and use appropriate clinical awareness, monitoring, and patient support as needed. Further clinical direction is provided in the notice. The notification is to be forwarded to users and to facilities where product was further distributed. The notice should be visible for awareness. Consignees with any questions can contact [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

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).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201116Abiomed 23 Fr SheathAbiomed, Inc. · 2020-06-15K192769Impella CP IntroducerAbiomed, Inc. · 2019-11-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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