Class I U.S. Food and Drug Administration

Abiomed, Inc. Automated Impella Controller labeled as the following recall: Potential for Automated Impella Controller (AIC) purge pressure issues

Recall published 12 months ago

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

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-0136-2026
Published
October 29, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Abiomed, Inc.
Product type
Medical devices
Units affected
9,177 total distributed units (754 pending correction)
Distribution
Nationwide
Made in
United States
Lot / code info
1. Product Code: 1000432; GTIN: 00813502013030; Serial Numbers pending correction as of 09/16/2025: IC11239, IC11238, IC10837, IC10497, IC10493, IC10338, IC10362. Serial Numbers corrected as of 09/16/2025: IC11404, IC11401, IC11400, IC11399, IC10827, IC11237, IC11236, IC11232, IC11231, IC11230, IC11227, IC11210, IC11182, IC11153, IC11145, IC11143, IC10854, IC10851, IC10849, IC10703, IC10300, IC10786, IC10785, IC10784, IC10762, IC10755, IC10727, IC10689, IC10672, IC10652, IC10651, IC10650, IC10631, IC10588, IC10586, IC10585, IC10584, IC10518, IC10517, IC10496, IC10494, IC10492, IC10483, IC10365, IC10364, IC10353, IC10170, IC11619, IC11616, IC11611, IC11600. 2. Product Code: 1000201; GTIN: 00813502010442; Serial Numbers pending correction as of 09/16/2025: IC9821, IC9820, IC9819, IC9818, IC9817, IC9816, IC9815, IC9814, IC9813, IC9641, IC9637, IC9636, IC9635, IC9633, IC9632, IC9629. 3. Product Code: 0042-0000-AU; GTIN: 00813502010886; Serial Numbers pending correction as of 09/16/2025: IC7289, IC7288, IC6531, IC5677, IC5521, IC5238, IC5237, IC5236. Serial Numbers corrected as of 09/16/2025: IC7850, IC7849, IC7290, IC7287, IC6530, IC6529, IC6528, IC6527, IC6526, IC5836, IC5752, IC5622, IC5525, IC5524, IC5523, IC5522, IC5341, IC5217, IC5216. 4. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers pending correction as of 09/16/2025: IC4944, IC2370, IC2369, IC2034, IC2032, IC1715, IC1665, IC1572, IC1544, IC1480. Serial Numbers corrected as of 09/16/2025: IC9416, IC9415, IC9414, IC9413, IC8283, IC7716, IC7695, IC7694, IC6636, IC6635, IC6634, IC6633, IC6083, IC6082, IC5824, IC5821, IC5680, IC5034, IC5050, IC4945, IC3803, IC3802, IC3662, IC3661, IC2687, IC2686, IC2035, IC2033, IC1913, IC1912, IC1911, IC1791, IC1790, IC1769, IC1664, IC1598, IC1595, IC1543, IC1481, IC1346, IC1324. 5. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers pending correction as of 09/16/2025: IC7686, IC7675, IC7584, IC7583, IC7582, IC7581, IC7454, IC7453, IC7452, IC7406, IC7395, IC6880, IC6581, IC6580, IC6578, IC6577, IC6510, IC6489, IC6434, IC6387, IC6386, IC6375, IC6374, IC6373, IC6372, IC6371, IC6370, IC6331, IC6294, IC6293, IC6216, IC6214, IC6165, IC6164, IC5780, IC5779, IC5777, IC5775, IC5687, IC5558, IC5520, IC5492, IC5467, IC5466, IC5465, IC5357, IC5356, IC5251, IC5055, IC4682, IC4681, IC4562, IC4507, IC4358, IC4329, IC4325, IC4257, IC4240, IC4069, IC4068, IC4054, IC3890, IC3888, IC3887, IC3812, IC3783, IC3780, IC3776, IC3720, IC3719, IC3718, IC3705, IC3704, IC3670, IC3666, IC3665, IC3664, IC3663, IC3660, IC3658, IC3656, IC3490, IC3309, IC3308, IC3307, IC3306, IC3302, IC3301, IC3144, IC3132, IC3131, IC3130, IC3129, IC3128, IC3127, IC3102, IC3099, IC3098, IC3050, IC3049, IC2989, IC2861, IC2860, IC2828, IC2827, IC2765, IC2677, IC2676, IC2607, IC2471, IC2479, IC2478, IC2477, IC2476, IC2557, IC2556, IC2444, IC2443, IC2442, IC2222, IC2219, IC2175, IC1876, IC1725, IC1724, IC1678, IC1677, IC1594, IC1577, IC1416, IC1411, IC1345, IC1305, IC1285, IC1284, IC1283, IC1280. Serial Numbers corrected as of 09/16/2025: IC7809, IC7748, IC7721, IC7720, IC7719, IC7718, IC7717, IC7693, IC7692, IC7691, IC7690, IC7689, IC7688, IC7687, IC7674, IC7667, IC7666, IC7655, IC7654, IC7653, IC7652, IC7651, IC7650, IC7649, IC7648, IC7647, IC7646, IC7615, IC7614, IC7613, IC7580, IC7579, IC7578, IC7577, IC7576, IC7421, IC7455, IC7407, IC7394, IC7393, IC7392, IC7390, IC7389, IC7388, IC7378, IC7286, IC7265, IC7264, IC7263, IC7262, IC7261, IC7260, IC7259, IC7258, IC7100, IC7099, IC7098, IC7097, IC7096, IC7095, IC7094, IC7093, IC7092, IC7087, IC7078, IC7077, IC7076, IC7075, IC6879, IC6878, IC6877, IC6876, IC6845, IC6843, IC6814, IC6813, IC6812, IC6810, IC6809, IC6808, IC6807, IC6806, IC6805, IC6804, IC6742, IC6741, IC6740, IC6739, IC6738, IC6728, IC6717, IC6716, IC6715, IC6714, IC6713, IC6712, IC6711, IC6710, IC6709, IC6708, IC6707, IC6706, IC6695, IC6694, IC6693, IC6692, IC6691, IC6690, IC6689, IC6688, IC6595, IC6594, IC6593, IC6592, IC6591, IC6590, IC6589, IC6588…
UPC codes
00813502013030, 00813502010442, 00813502010886, 00813502011272, 00813502011289

Products covered by this recall

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP. 8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK. 9. Impella Controller, Packaged, US, Product Code: 0042-0000-US. 10. Impella Optical Controller, Packaged, AU, Product Code: 0042-0010-AU. 11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU. 12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN. 13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK. 14. Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US. 15. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP. 16. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L. 17. Optical AIC w/Impella Connect, Pack'd, CA, Product Code: 0042-0040-CA. 18. Optical AIC w/Impella Connect, Pack'd, EU, Product Code: 0042-0040-EU. 19. Optical, AIC, Impella Connect, Pkgd, AU, Product Code: 0042-0040-AU. 20. Optical, AIC, Impella Connect, Pkgd, UK, Product Code: 0042-0040-UK. 21. Optical, AIC, Impella Connect, Pkgd, US, Product Code: 0042-0040-US.

Check your product

The notice names 27 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.

  • 00813502013030
  • 00813502010442
  • 00813502010886
  • 00813502011272
  • 00813502011289

Model or item number

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

  • 1. AIC w
  • 1000201. 3. Impella Controller
  • AU
  • 0042-0000-CA. 5. Impella Controller
  • EU
  • 0042-0000-EU. 6. Impella Controller
  • IN
  • 0042-0000-IN. 7. Impella Controller
  • JP
  • 0042-0000-JP. 8. Impella Controller
  • UK
  • 0042-0000-UK. 9. Impella Controller
  • US
  • 0042-0040-EU. 19. Optical
  • AIC
  • 0042-0040-AU. 20. Optical
  • 0042-0040-UK. 21. Optical
  • 1000201
  • 0042-0000-AU
  • 0042-0000-CA

Serial number

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

  • 16
  • 2025

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. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

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 for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00813502013030, 00813502010442, 00813502010886; model number 1. AIC w, 1000201. 3. Impella Controller, AU. 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?

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.

Related recalls