Class I U.S. Food and Drug Administration

Abiomed, Inc. Impella Optical Controller, Automated Impella Controller recall: The potential for purge cassette recognition issues due to the failure

Recall published last month

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

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: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

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-3150-2026
Published
September 23, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Abiomed, Inc.
Product type
Medical devices
Units affected
4100 units (2785 US, 1315 OUS) 11 10
Distribution
Nationwide
Made in
United States
Lot / code info
1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU; UDI-DI: 00813502012972; Serial Numbers: IC12674, IC12675, IC13066, IC10162, IC10163, IC10387, IC10388, IC10747, IC10748, IC11472, IC11487, IC11489, IC11490, IC11544, IC11546, IC11566, IC12008, IC12054, IC12151, IC12583, IC12584, IC12804, IC13070, IC13071, IC13085, IC13093, IC13094, IC13095, IC13096, IC13233, IC13234, IC13561, IC13566, IC13749, IC13753; 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA; UDI-DI: 00813502012958; Serial Numbers: IC10306, IC10312, IC11171, IC11172, IC12604, IC12605, IC12891, IC12892, IC12894, IC12895, IC13266, IC13267, IC13503, IC13504, IC13617, IC13618, IC13713, IC13714, IC13715, IC13716, IC13726, IC13801, IC13802; 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU; UDI-DI: 00813502012217 Serial Numbers: IC10382, IC10419, IC10681, IC10683, IC11123, IC11125, IC11257, IC11258, IC11262, IC11264, IC11265, IC11266, IC11282, IC12012, IC12015, IC12447, IC12483, IC12814, IC13029, IC13030, IC13031, IC9010, IC9011, IC9949, IC9950, IC10146, IC10180, IC10371, IC10372, IC10396, IC10397, IC10665, IC10670, IC10671, IC10673, IC10721, IC10772, IC10828, IC10835, IC11072, IC11116, IC11119, IC11132, IC11138, IC11140, IC11146, IC11679, IC11706, IC11712, IC11713, IC11721, IC11878, IC11951, IC11958, IC11967, IC11969, IC11978, IC11986, IC11992, IC11997, IC12260, IC12261, IC12446, IC12454, IC12458, IC12459, IC12463, IC12465, IC12466, IC12544, IC12546, IC12555, IC12565, IC12566, IC12586, IC12593, IC12594, IC12595, IC12596, IC12666, IC12670, IC12744, IC12747, IC12749, IC12750, IC12761, IC12764, IC12771, IC12810, IC12822, IC12828, IC12845, IC12929, IC13034, IC13035, IC13041, IC13047, IC13053, IC13118, IC13122, IC13135, IC13199, IC13226, IC13245, IC13246, IC13360, IC13364, IC13627, IC13635, IC13640, IC13642, IC12768, IC13023, IC13322, IC9071, IC9073, IC10126, IC10139, IC10169, IC10174, IC10392, IC10556, IC10558, IC10628, IC10632, IC10674, IC10677, IC10678, IC10680, IC11215, IC11217, IC11219, IC11220, IC11281, IC11283, IC11289, IC11358, IC11879, IC11904, IC11911, IC11930, IC11945, IC11952, IC11959, IC11960, IC11961, IC11966, IC11970, IC11973, IC11974, IC11976, IC11989, IC11991, IC12195, IC12206, IC12210, IC12213, IC12216, IC12217, IC12257, IC12258, IC12262, IC12265, IC12267, IC12269, IC12270, IC12272, IC12273, IC12274, IC12276, IC12277, IC12307, IC12309, IC12310, IC12319, IC12455, IC12456, IC12457, IC12467, IC12481, IC12484, IC12485, IC12488, IC12491, IC12494, IC12548, IC12551, IC12553, IC12765, IC12767, IC12812, IC12816, IC12824, IC12835, IC12942, IC12951, IC13177, IC13192, IC13291, IC13298, IC13328, IC13329, IC13330, IC13331, IC13352, IC13354, IC13363, IC13365, IC13366, IC13628, IC13636, IC9726, IC9727, IC9729, IC9730, IC9761, IC9830, IC9959, IC9965, IC10154, IC10159, IC10171, IC10175, IC10394, IC10400, IC10938, IC10952, IC11305, IC11715, IC11722, IC12001, IC12220, IC12221, IC12524, IC12542, IC12671, IC12672, IC8840, IC9252, IC9757, IC9759, IC10779, IC10782, IC10181, IC10184, IC10185, IC10186, IC10326, IC10360, IC10369, IC10540, IC10541, IC10544, IC10551, IC10555, IC10559, IC10627, IC10639, IC10679, IC10682, IC10707, IC10710, IC10711, IC10713, IC10809, IC11007, IC11010, IC11011, IC11090, IC11221, IC11223, IC11234, IC11363, IC11368, IC11717, IC11718, IC11719, IC11910, IC11913, IC11931, IC11948, IC11949, IC11955, IC11980, IC11983, IC12259, IC12263, IC12264, IC12266, IC12281, IC12282, IC12290, IC12311, IC12314, IC12486, IC12490, IC12496, IC12497, IC12576, IC12577, IC12695, IC12696, IC12697, IC12698, IC12699, IC12700, IC12702, IC12703, IC12704, IC12753, IC12754, IC12755, IC12756, IC12757, IC12802, IC12809, IC13069, IC13072, IC13120, IC13121, IC13133, IC13134, IC13136, IC13138, IC13165, IC13213, IC13248, IC13249, IC13281, IC13282, IC13293, IC13297, IC13371, IC13372, IC13565, IC13638, IC13639, IC13643, IC13645, IC13650, IC13653, IC8821, IC8822, IC8823, IC8825, IC8826, IC9002A, IC9015, IC9023, IC9024, IC9051…
UPC codes
00813502012972, 00813502012958, 00813502012217

Products covered by this recall

Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 3. Optical, AIC, Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 4. Optical, AIC, Impella Connect, Packaged, JP; Product Code: 0042-0040-JP. 5. Optical, AIC, Impella Connect, Packaged, UK; Product Code: 0042-0040-UK. 6. Optical, AIC, Impella Connect, Packaged, US; Product Code: 0042-0040-US. 7. Optical, AIC, Impella Connect, Packaged, KR; Product Code: 0042-0040-KR;

Check your product

The notice names 29 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.

  • 00813502012972
  • 00813502012958
  • 00813502012217

Model or item number

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

  • 0042-0040-AU. 2. Optical
  • AIC
  • 0042-0040-CA. 3. Optical
  • 0042-0040-EU. 4. Optical
  • 0042-0040-JP. 5. Optical
  • 0042-0040-UK. 6. Optical
  • 0042-0040-US. 7. Optical
  • 0042-0040-KR
  • 0042-0040-AU
  • 0042-0040-CA
  • 0042-0040-EU

Serial number

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

  • IC12674
  • IC12675
  • IC13066
  • IC10162
  • IC101
  • IC10306
  • IC10312
  • IC11171
  • IC11172
  • IC126
  • IC10382
  • IC10419
  • IC10681
  • IC10683
  • IC111

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 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.

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?

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00813502012972, 00813502012958, 00813502012217; model number 0042-0040-AU. 2. Optical, AIC, 0042-0040-CA. 3. Optical. 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.

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