Abiomed, Inc. recalls Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and…
Increased risk of purge leaks with Generation 1 purge cassettes.
Read the official notice →- Date
- 2026-04-08
- Country
- United States
- Brand
- Abiomed
- Product
- Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and…
- Classification
- Class I
- Units
- Worldwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Abiomed recalls
- 2026-06-03
USAbiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,…
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper…
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Abiomed, Inc. recalls Automated Impella Controller (AIC); Product Code: 0042-0000-US;
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process;…
FDA · DeviceAbiomed, Inc.Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA,…Official notice → - 2026-04-08
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Abiomed, Inc. recalls Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA;…
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
FDA · DeviceAbiomed, Inc.International distribution in the country of Australia, Canada, France,…Official notice → - 2026-03-11
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FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Canada,…Official notice → - 2026-01-14
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Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Device packaged in incorrect outer box carton.
FDA · DeviceAbiomed, Inc.International distribution to the country of Australia and Taiwan.Official notice → - 2025-10-29
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Abiomed, Inc. recalls Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product…
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
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Other drugs & medical recalls in the United States
- 2026-04-08
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Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
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Baxter Healthcare Corporation recalls Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy…
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or…
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Abiomed, Inc. recalls Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA;…
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
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Amneal Pharmaceuticals, LLC recalls Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only,…
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
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Appco Pharma LLC recalls Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by:…
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