Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Johnson & JohnsonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record. See the Johnson & Johnson group view.
As of Nov 14, 2026, FDA's public records list Abiomed with 86 device recalls and 19 510(k) clearances. The most recent is a device recall dated Sep 18, 2026: Automated Impella Controller, Packaged. Primary user control interface for the Impella C….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 18, 2026 | Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.Class I · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software upd | Device recalls |
| Sep 18, 2026 | Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.Class I · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software upd | Device recalls |
| Sep 18, 2026 | Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.Class I · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software upd | Device recalls |
| Aug 12, 2026 | Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA;Class I · The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure | Device recalls |
| Aug 12, 2026 | Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU;Class I · The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure | Device recalls |
| Aug 12, 2026 | Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding ProdClass I · The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure | Device recalls |
| Jun 11, 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 Class I · A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr an | Device recalls |
| Oct 8, 2025 | 14Fr Low Profile Introducer KitK252766 · DYB | 510(k) clearances |
| Aug 6, 2024 | Abiomed 14Fr Low Profile Introducer KitK241708 · DYB | 510(k) clearances |
| Jun 30, 2023 | preCARDIA Occlusion SystemK221294 · MJN | 510(k) clearances |
| Feb 23, 2023 | OXY-1 SystemK223161 · DTZ | 510(k) clearances |
| Oct 13, 2022 | Abiomed 14Fr Low Profile Introducer SetK222113 · DYB | 510(k) clearances |
| Dec 7, 2020 | Impella XR Sheath SetK202330 · DYB | 510(k) clearances |
| Oct 23, 2020 | OXY-1 SystemK200109 · DTZ | 510(k) clearances |
| Jun 15, 2020 | Abiomed 23 Fr SheathK201116 · DYB | 510(k) clearances |
| Feb 19, 2019 | Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,Class II · Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) fi | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
