PlainRecalls

Abiomed, Inc.

Compiled from official public sources by the publisher.

79 recalls on record · Latest: Jul 22, 2026

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Agency notice ledger

Federal filing book Abiomed, Inc. MID-BOOK · SINGLE-AGENCY

#225 of 14,151 · 79 notices · 0.076% archive

  • BOOK 79 notices
  • RANK #225 of 14,151
  • SHARE 0.076% archive
  • AGENCY FDA Devices (79)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 22, 2026
  • PHOTO Key Pharmacy

Nearest notice-volume peer: Key Pharmacy and Compounding Center (0 notice gap)

Abiomed, Inc. accounts for about 0.076% of the 104,423-notice archive on 79 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Abiomed, Inc.'s standing among 14,151 recalling firms

Abiomed, Inc. ranks 225th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Abiomed, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

79 225th of 14151 higher than 13,921 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Abiomed, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Abiomed, Inc. holds about 0.076% of archive notices alongside 79 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Sep 11, 2024

Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
FDA Devices Critical Jul 24, 2024

Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
FDA Devices Moderate Feb 28, 2024

Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
FDA Devices Moderate Feb 21, 2024

Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 100080 an
FDA Devices Critical Feb 21, 2024

Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist ***Updated February 2024*** (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.
FDA Devices Moderate Jan 17, 2024

Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046
FDA Devices Moderate Jan 17, 2024

Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
FDA Devices Moderate Jan 17, 2024

Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)
FDA Devices Moderate Jan 17, 2024

Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053
FDA Devices Moderate Jan 17, 2024

Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015
FDA Devices Moderate Jan 17, 2024

Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052
FDA Devices Moderate Jan 17, 2024

Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
FDA Devices Moderate Jan 17, 2024

Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
FDA Devices Moderate Jan 17, 2024

Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
FDA Devices Moderate Jan 17, 2024

Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056
FDA Devices Moderate Jan 10, 2024

Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
FDA Devices Moderate Dec 13, 2023

Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
FDA Devices Moderate Dec 13, 2023

Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
FDA Devices Critical Aug 9, 2023

Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
FDA Devices Critical Jul 26, 2023

Impella LD intravascular micro axial blood pump, Product Number 005082
FDA Devices Critical Jul 26, 2023

Impella 5.0 intravascular micro axial blood pump, Product Number 005062
FDA Devices Critical Jul 26, 2023

Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
FDA Devices Critical Jul 26, 2023

Impella 2.5 intravascular micro axial blood pump, Product Number 005042
FDA Devices Critical Jul 26, 2023

Impella CP intravascular micro axial blood pump, Product Number 0048-0032
FDA Devices Critical Jul 26, 2023

Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
FDA Devices Moderate Jul 19, 2023

Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
FDA Devices Critical May 24, 2023

Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
FDA Devices Critical Feb 9, 2022

OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
FDA Devices Moderate Nov 13, 2019

lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI

Abiomed, Inc. carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (79 here — heavy-book).

Key Pharmacy and Compounding Center 79 Lyons Magnus, Inc 79 Philips Medical Systems Nederlands 79 Randox Laboratories Ltd. 79 Suzuki 79

Frequently Asked Questions

How many federal recall notices name Abiomed, Inc.? ▼
PlainRecalls indexes 79 distinct federal recall events naming Abiomed, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Abiomed, Inc. sit among other recalling firms? ▼
Abiomed, Inc. ranks #225 of 14,151 by distinct recall-event count among 14,151 firms in this archive (98th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Abiomed, Inc.'s notices? ▼
FDA Devices accounts for 79 of this firm's 79 indexed notices.
What product category dominates Abiomed, Inc.'s filing book? ▼
Filings for Abiomed, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Abiomed, Inc.: 79 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Abiomed, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026