Class I U.S. Food and Drug Administration

Abiomed, Inc. Automated Impella Controller , for use with left heart support blood recall: Potential software error in the Automated Impella Controller ("AIC" )

Recall published 4 months ago

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

The hazard: Device malfunction

A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

What the notice says: Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2360-2026
Published
June 24, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Abiomed, Inc.
Product type
Medical devices
Units affected
10,297 units
Distribution
Nationwide
Made in
United States
Lot / code info
All products below with software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above. 1. Product Code: 0042-0000-AU; GTIN: 00813502010886; Serial Numbers: IC5341, IC5523, IC5677, IC6531, IC5525, IC6529, IC5836, IC5524, IC7849, IC7850, IC7287, IC7288, IC7289, IC7290, IC6527, IC6526, IC6528, IC6530, IC5622, IC5752, IC5521, IC5522, IC5217, IC5216. 2. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC9415, IC9413, IC9416, IC9414, IC8283, IC7716, IC7695, IC7694, IC6635, IC6636, IC6633, IC6634, IC6082, IC6083, IC5821, IC5824, IC5680, IC3802, IC2035, IC1912, IC5034, IC5050, IC4944, IC4945, IC3803, IC3661, IC3662, IC2686, IC2687, IC2033, IC1913, IC1790, IC1791, IC1911, IC1715, IC1769, IC1664, IC1595, IC1598, IC1543, IC1480, IC1481, IC1324, IC1346. 3. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC7809, IC7720, IC7721, IC7748, IC7719, IC7718, IC7717, IC7691, IC7692, IC7693, IC7689, IC7690, IC7687, IC7688, IC7675, IC7686, IC7674, IC7667, IC7655, IC7666, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC7646, IC7653, IC7654, IC7613, IC7614, IC7615, IC7580, IC7578, IC7579, IC7576, IC7577, IC7421, IC7455, IC7407, IC7395, IC7406, IC7393, IC7394, IC7388, IC7389, IC7390, IC7392, IC7378, IC7286, IC7265, IC7263, IC7264, IC7261, IC7262, IC7258, IC7259, IC7260, IC7098, IC7099, IC7100, IC7078, IC7093, IC7087, IC7092, IC7096, IC7097, IC7094, IC7095, IC7077, IC7075, IC7076, IC6880, IC6876, IC6877, IC6878, IC6879, IC6845, IC6843, IC6813, IC6814, IC6810, IC6812, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC6716, IC6717, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6713, IC6714, IC6710, IC6712, IC6711, IC6715, IC6708, IC6709, IC6594, IC6595, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6591, IC6592, IC6593, IC6579, IC6577, IC6578, IC6587, IC6588, IC6589, IC6590, IC6582, IC6580, IC6581, IC6534, IC6535, IC6536, IC6487, IC6488, IC6449, IC6469, IC6441, IC6443, IC6440, IC6436, IC6437, IC6439, IC6432, IC6435, IC6434, IC6431, IC6331, IC6270, IC6064, IC6205, IC6275, IC6273, IC6274, IC6225, IC6236, IC6272, IC6223, IC6224, IC6149, IC6150, IC6151, IC6147, IC6081, IC6078, IC5818, IC5817, IC5781, IC5775, IC5777, IC5779, IC5755, IC5756, IC5754, IC5715, IC5716, IC5717, IC5685, IC5686, IC5611, IC5714, IC5722, IC5683, IC5684, IC5688, IC5560, IC5681, IC5682, IC5559, IC5518, IC5520, IC5517, IC5177, IC4839, IC4565, IC5519, IC5495, IC5496, IC5494, IC5490, IC5491, IC5492, IC5493, IC5487, IC5488, IC5476, IC5477, IC5460, IC5461, IC5463, IC5464, IC5462, IC5443, IC5441, IC5442, IC5440, IC5435, IC5436, IC5433, IC5434, IC5331, IC5356, IC5421, IC5422, IC5391, IC5392, IC5252, IC5195, IC5048, IC5193, IC5194, IC5178, IC5175, IC5176, IC5173, IC5174, IC5210, IC5212, IC5171, IC5169, IC5086, IC5051, IC5053, IC5075, IC5057, IC5087, IC5088, IC5046, IC5047, IC5049, IC5008, IC5009, IC4973, IC5007, IC4984, IC4986, IC4987, IC4988, IC4933, IC4934, IC4931, IC4932, IC4850, IC4928, IC4929, IC4930, IC4623, IC4470, IC4912, IC4917, IC4913, IC4915, IC4914, IC4916, IC4846, IC4837, IC4833, IC4834, IC4835, IC4836, IC4823, IC4824, IC4821, IC4822, IC4845, IC4840, IC4819, IC4820, IC4817, IC4818, IC4815, IC4816, IC4796, IC4797, IC4792, IC4793, IC4794, IC4795, IC4763, IC4790, IC4791, IC4781, IC4762, IC4760, IC4761, IC4758, IC4759, IC4748, IC4757, IC4737, IC4738, IC4735, IC4736, IC4733, IC4734, IC4723, IC4724, IC4728, IC4729, IC4725, IC4727, IC4679, IC4680, IC4677, IC4678, IC4657, IC4658, IC4648, IC4649, IC4646, IC4647, IC4645, IC4656, IC4634, IC4635, IC4636, IC4632, IC4633, IC4630, IC4631, IC4585, IC4629, IC4626, IC4624, IC4627, IC4613, IC4614, IC4611, IC4569, IC4566, IC4568, IC4610, IC4612, IC4609, IC4597, IC4598, IC4557, IC4567, IC4594, IC4595, IC4559, IC4564, IC4560, IC4561, IC4562, IC4563, IC4505, IC4506, IC4508, IC4501, IC4471, IC4500, IC4469, IC4466, IC4467, IC4464, IC4465, IC4468, IC4442, IC4443, IC4444, IC4445, IC4446, IC4370, IC4371, IC4367, IC4365, IC4366, IC4361, IC4359, IC4360, IC4358, IC4329, IC4328, IC4234, IC4362, IC…
UPC codes
00813502010886, 00813502011272, 00813502011289

Products covered by this recall

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 Controller, Packaged, UK; Product Code: 0042-0000-UK. 7. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US. 13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP. 16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.

Check your product

The notice names 38 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.

  • 00813502010886
  • 00813502011272
  • 00813502011289

Model or item number

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

  • 1. Impella Controller
  • AU
  • 0042-0000-AU. 2. Impella Controller
  • CA
  • 0042-0000-CA. 3. Impella Controller
  • EU
  • 0042-0000-EU. 4. Impella Controller
  • IN
  • 0042-0000-IN. 5. Impella Controller
  • JP
  • 0042-0000-JP. 6. Impella Controller
  • UK
  • 0042-0000-UK. 7. Impella Controller
  • US
  • 0042-0010-UK. 12.Impella Optical Controller
  • 0042-0040-JP. 16. Optical
  • AIC
  • 0042-0040-AU. 17. Optical
  • 0042-0040-UK. 18. Optical
  • 0042-0000-AU

Serial number

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

  • IC5341
  • IC5523
  • IC5677
  • IC6531
  • IC5525
  • IC9415
  • IC9413
  • IC9416
  • IC9414
  • IC8283
  • IC7809
  • IC7720
  • IC7721
  • IC7748
  • IC7719

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 Malfunction

Abiomed, Inc. — A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Report device problems to the FDA through MedWatch — that database is where this recall came from.
  3. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.
  4. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

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?

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices. Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00813502010886, 00813502011272, 00813502011289; model number 1. Impella Controller, AU, 0042-0000-AU. 2. Impella Controller. 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 listed on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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