Use cautionMedical device recall · FDA · Published December 27, 2023
Abiomed Impella Catheters Recall: Risk of Left Ventricle Perforation
Abiomed recalls Impella 2.5, 5.0, 5.5 and other catheters due to potential left ventricle perforation from improper handling. Affected units include specific product codes and sets. No action needed if device is properly used.
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
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Contact the company
📍Recalling firmAbiomed, Inc.24 Cherry Hill Dr · Danvers, MA 01923-2575
✎ GovInfoNow plain-language explainer
Abiomed is recalling several Impella catheters that support circulatory systems. The recall is due to a risk of the device perforating the heart's left ventricle if handled incorrectly by medical professionals. This is a serious hazard that requires immediate attention from healthcare providers using these devices. Read more at govinfonow.com/recall/56466-abiomed-impella-catheters-recall-risk-of-left-ventricle-perforation.
“Abiomed Impella Catheters Recall: Risk of Left Ventricle Perforation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56466-abiomed-impella-catheters-recall-risk-of-left-ventricle-perforation. Based on FDA recall #Z-0980-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0980-2024%22&limit=1).
Abiomed, Inc. recalled Impella catheters on Dec. 27, 2023, according to the FDA. The recall addresses updated instructions for use warning of inlet perforation through the left ventricle's myocardial wall. This Class I voluntary recall affects 91,914 units distributed worldwide.
How to tell if you have it
Impella 2.5 (Product Code 005042)
Impella 5.0 (Product Code 005062)
Impella LD (Product Code 005082)
Impella 5.5 with SmartAssist (Product Codes 0550-0008 and 1000100)
Impella CP (Product Code 0048-0032)
Impella CP with SmartAssist (Product Codes 1000080 and 0048-0045)
Impella 2.5 Set (004413)
Impella 5.0 Pump Set ROW (0046-0026)
Impella 5.0 Pump Set APAC (0046-0037)
5.0 Pump Set AU (004680-AU)
Impella CP Pump Set, EU (0048-0002)
Impella CP Pump Set BR (0048-0002-BR)
Impella CP Pump Set, Canada (0048-0004)
Impella CP Smart Assist Set, EU (0048-0014)
Impella CP Smart Assist Set, JP (0048-0024-JP)
Impella CP Smart Assist Set, Canada (0048-0044)
Impella CP Smart Assist Set APAC (0048-0047)
Impella 2.5 IMC Pump Set EU (005040)
Impella 2.5 Pump Set, Japan (005048-JP)
Impella 5.0 IMC Pump Set EU (005060)
Impella 5.0 IMC Pump Set Canada (005064)
Impella 5.0 Pump Set, Japan (005066-JP)
Impella 5.5 with SmartAssist Set, EU (0550-0002)
Impella 5.5 with SmartAssist Set, CA (0550-0004)
Impella CP Pump set, APAC (1000115)
Impella 5.5 SmartAssist Set, JP (1000211)
Impella CP with SmartAssist APAC (1000302)
Impella 5.5 Set AU (1000361)
Impella CP Smart Assist Set (1000402)
The hazard
The recall stems from an update to the Instructions for Use (IFU) warning that operator handling may cause the inlet to perforate through the myocardial wall of the left ventricle. The record does not report specific incidents or injuries associated with this hazard.
Context
GovInfoNow's records show Abiomed, Inc. has 28 other recalls on file since Sept. 4, 2019. Other recent recalls of similar products include the Impella Controller purge cassette recognition issues (Aug. 12, 2026), the Impella CP Smart Assist Set introducer sheath leakage risk (June 11, 2026), and the Impella CP Set blood clot risk (May 22, 2026). Other recent recalls of similar products include the Penumbra RED 62 Reperfusion Catheter fracture risk (July 24, 2026), the Medline ViewFlex Xtra ICE Catheters infection risk (Dec. 22, 2025), and the Medline Heart Cath Pack-LF Kits particulate risk (March 24, 2026).
How to tell if you have this one
Check for product codes listed in the recall notice: Impella 2.5 (005042), Impella 5.0 (005062), Impella 5.5 (0550-0008), and other specific models with SmartAssist features. The recall includes various pump sets and regional versions.
Brand
Abiomed
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Review Product Information
Check the product codes on your Impella catheter or pump set to confirm if it's affected. The recall includes specific product codes like 005042 for Impella 2.5.
Verify Device Handling
Ensure proper handling procedures are followed as per the updated instructions to avoid potential perforation of the heart's left ventricle.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Are all Impella catheters affected by this recall?
No. The recall specifically affects Impella 2.5, 5.0, 5.5, and CP models with certain product codes. Right-side devices like Impella RP are not included.
What should I do if I have an affected product?
Check the product code on your device. If it matches the listed codes, follow the updated instructions for safe handling. No return is required as the issue is addressed through proper use.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0980-2024 (December 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0980-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.