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 Critical Jul 22, 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
FDA Devices Critical Jul 22, 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
FDA Devices Critical Jul 22, 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
FDA Devices Critical Jul 22, 2026

ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
FDA Devices Critical Jul 22, 2026

ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
FDA Devices Critical Jul 22, 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
FDA Devices Critical Jul 22, 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
FDA Devices Critical Jul 22, 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
FDA Devices Critical Jul 22, 2026

ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
FDA Devices Critical Jul 22, 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
FDA Devices Critical Jul 22, 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
FDA Devices Critical Jul 22, 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
FDA Devices Critical Jul 22, 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
FDA Devices Critical Jul 1, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
FDA Devices Critical Jul 1, 2026

Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
FDA Devices Critical Jul 1, 2026

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
FDA Devices Critical Jul 1, 2026

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
FDA Devices Critical Jun 24, 2026

Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
FDA Devices Critical Jun 24, 2026

Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella C
FDA Devices Critical Jun 3, 2026

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
FDA Devices Critical Jun 3, 2026

Automated Impella Controller (AIC); Product Code: 0042-0000-US;
FDA Devices Critical Apr 8, 2026

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Prod
FDA Devices Critical Apr 8, 2026

Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product C
FDA Devices Critical Mar 11, 2026

Impella RP Flex with SmartAssist. Product Code: 1000323.
FDA Devices Critical Mar 11, 2026

Impella RP with SmartAssist. Product Code: 0046-0035.
FDA Devices Critical Mar 11, 2026

Impella RP. Product Code: 0046-0011.
FDA Devices Moderate Jan 14, 2026

Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
FDA Devices Critical Oct 29, 2025

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Con
FDA Devices Critical Oct 15, 2025

Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controll
FDA Devices Critical Oct 1, 2025

Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 4. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, UK, Loaner; Product Code: 0
FDA Devices Critical Aug 6, 2025

Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product

FDA Devices Critical Jan 22, 2025

Impella RP Flex with SmartAssist; Product Number: 1000323;
FDA Devices Critical Jan 22, 2025

Impella RP with SmartAssist; Product Number: 0046-0035;
FDA Devices Moderate Sep 11, 2024

ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
FDA Devices Moderate Sep 11, 2024

Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
FDA Devices Moderate Sep 11, 2024

Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
FDA Devices Moderate Sep 11, 2024

Pump 381 Pump Set (US); Product Code: 1000080;
FDA Devices Moderate Sep 11, 2024

Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
FDA Devices Moderate Sep 11, 2024

Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
FDA Devices Moderate Sep 11, 2024

Impella CP Smart Assist Set; Product Code: 1000402;
FDA Devices Moderate Sep 11, 2024

Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
FDA Devices Moderate Sep 11, 2024

Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
FDA Devices Moderate Sep 11, 2024

Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
FDA Devices Moderate Sep 11, 2024

Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
FDA Devices Moderate Sep 11, 2024

Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
FDA Devices Moderate Sep 11, 2024

Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
FDA Devices Moderate Sep 11, 2024

Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
FDA Devices Moderate Sep 11, 2024

Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
FDA Devices Moderate Sep 11, 2024

Pump 371 14F LT CMR Set; Product Code: 0048-0045;
FDA Devices Moderate Sep 11, 2024

Impella 5.5 Set AU; Product Code: 1000361;

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