Class II U.S. Food and Drug Administration

Abiomed, Inc. Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set recall: Device packaged in incorrect outer box carton

Recall published 9 months ago

Device packaged in incorrect outer box carton.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Device packaged in incorrect outer box carton.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1030-2026
Published
January 14, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Abiomed, Inc.
Product type
Medical devices
Units affected
6 units
Made in
United States
Lot / code info
Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27. *** UPDATE 05/02/2026*** Serial numbers added: 621448, 621449, 621450, and 621451;
UPC codes
00813502012828

Products covered by this recall

Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00813502012828

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 30
  • 27

Model or item number

On the rating label, the box or the instruction sheet.

  • 1000482

Serial number

On the rating plate, often next to the date of manufacture.

  • 621454

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Abiomed, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Abiomed, Inc. — 22 Cherry Hill Dr, Danvers, MA, 01923-2575

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Abiomed, Inc. medical devices recalled?

Device packaged in incorrect outer box carton. Device packaged in incorrect outer box carton.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00813502012828; best-by date 30 or 27; model number 1000482. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

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