FDA recall, Posted Oct 28, 2026, High risk

Abiomed Impella Controllers

The controller may have an RFID firmware issue causing failure to recognize the purge cassette.

Summary by Recall Canary from the FDA notice

Abiomed, Inc., of Danvers, Massachusetts, is voluntarily recalling certain Automated Impella Controllers, Impella Connect Optical AICs, and Impella Optical Controllers, which are primary user control interfaces for the Impella Catheter, a catheter-based heart pump.

The recall follows a retrospective review of servicing records that identified units requiring hardware, firmware, and/or software updates due to an RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change, potentially causing a delay in procedure or therapy.

The recall began September 18, 2026, and was added to the FDA's Enforcement Report on October 28, 2026. The products were distributed nationwide in the US and to numerous countries including Belgium, Brazil, Canada, and Germany, among others. Customers were notified by letter.

More software defect recalls

What to do

The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:

A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
Talk to your health care provider before you stop using it.

Is yours affected?

3 products

Affected if its UDI-DI and serial number are listed under that product.

A UDI-DI is the device identifier printed with the barcode on the device label.

Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump
UDI-DI
00813502010022
00813502011296
00813502011289
00813502011418
00813502011272
Serial number
IC1014
IC1029
IC1038
IC1043
IC1042
IC1061
IC1075
IC1096
IC1122
IC1190
IC1202
IC1203
IC1224
IC1231
IC1238
IC1269
IC1289
IC1446
IC1612
IC1741
IC1771
IC1852
IC1853
IC1708
IC1964
IC2071
IC2069
IC2154
IC2227
IC2314
IC2315
IC2029
IC2321
IC2428
IC2429
IC2521
IC2561
IC2562
IC2575
IC2664
IC2665
IC2691
IC2692
IC2739
IC2782
IC2840
IC2841
IC2848
IC2891
IC2976
All 428
IC2977
IC3009
IC3010
IC3154
IC3155
IC3244
IC3246
IC3342
IC3398
IC3347
IC3351
IC3512
IC3609
IC3714
IC3715
IC3772
IC3773
IC3806
IC3822
IC3823
IC3919
IC3975
IC3976
IC4041
IC4042
IC4045
IC4060
IC4250
IC4259
IC4295
IC4339
IC4616
IC4640
IC4641
IC4708
IC4831
IC4832
IC4884
IC5120
IC5151
IC5201
IC5056
IC5549
IC5605
IC5661
IC5662
IC5598
IC5720
IC5721
IC5745
IC5749
IC5750
IC5828
IC5984
IC6042
IC6321
IC6322
IC6328
IC6329
IC6359
IC6360
IC6403
IC6596
IC6597
IC6622
IC6623
IC6632
IC6637
IC6673
IC6825
IC6846
IC6834
IC6835
IC1387
IC1869
IC1909
IC2277
IC2278
IC2871
IC2872
IC3293
IC3294
IC3295
IC3674
IC3675
IC3784
IC3785
IC4741
IC5219
IC5220
IC5553
IC5911
IC5912
IC5926
IC5927
IC6289
IC6286
IC6287
IC6540
IC6583
IC6584
IC6585
IC6845
IC6925
IC7057
IC7074
IC7073
IC7441
IC7442
IC7591
IC1285
IC1416
IC3719
IC3720
IC3776
IC1825
IC1876
IC2175
IC2857
IC2996
IC3296
IC3486
IC3488
IC3890
IC4055
IC4323
IC4681
IC4682
IC4892
IC4984
IC4987
IC4973
IC5048
IC5421
IC5442
IC5464
IC5494
IC5687
IC5611
IC5722
IC5818
IC6065
IC6536
IC6582
IC6588
IC6589
IC6688
IC6694
IC6706
IC6707
IC6728
IC6738
IC6739
IC6740
IC6877
IC7388
IC7389
IC7390
IC7647
IC7649
IC7651
IC7652
IC7776
IC7777
IC5833
IC7444
IC7445
IC7446
IC7447
IC1284
IC1545
IC2368
IC2989
IC4331
IC4438
IC4856
IC2099
IC2823
IC3668
IC4099
IC4218
IC4611
IC4932
IC5490
IC5493
IC7407
IC7675
IC7686
IC7691
IC7692
IC7721
IC7809
IC3575
IC3576
IC3837
IC4065
IC4066
IC4451
IC4452
IC6330
IC3131
IC3132
IC2234
IC2469
IC3331
IC3669
IC3777
IC3828
IC4150
IC1396
IC1397
IC1724
IC1725
IC3050
IC5755
IC5756
IC3301
IC3302
IC3312
IC4675
IC4676
IC1577
IC1594
IC2877
IC6708
IC6806
IC5184
IC5218
IC7443
IC7585
IC5995
IC5996
IC5997
IC5998
IC5999
IC6001
IC6252
IC6253
IC6254
IC6139
IC6476
IC6477
IC6478
IC6475
IC7079
IC7080
IC7408
IC7409
IC7410
IC7411
IC3174
IC3166
IC3167
IC3213
IC3223
IC3475
IC4441
IC4525
IC5215
IC5910
IC7087
IC1280
IC1283
IC1345
IC1411
IC1398
IC2240
IC2557
IC3017
IC3178
IC3179
IC3322
IC3319
IC3490
IC3660
IC3813
IC4232
IC4237
IC4240
IC4242
IC4469
IC4626
IC4737
IC1586
IC1677
IC2021
IC2206
IC2245
IC3016
IC3049
IC3494
IC4329
IC4358
IC4563
IC4723
IC5757
IC6079
IC6080
IC6431
IC6580
IC6581
IC7719
IC3704
IC3705
IC5055
IC1766
IC5435
IC2451
IC2452
IC2453
IC2459
IC2460
IC2461
IC2449
IC1001
IC1179
IC1346
IC1481
IC1595
IC1715
IC1769
IC1790
IC1791
IC1911
IC1913
IC1912
IC2033
IC2035
IC2687
IC3661
IC3662
IC3802
IC4944
IC5034
IC5821
IC5824
IC6082
IC6083
IC6633
IC6636
IC7695
IC7716
IC9413
IC9414
IC9416
IC2442
IC2444
IC2443
IC2476
IC2477
IC2478
IC2479
IC2471
IC3127
IC3128
IC3129
IC3130
IC3306
IC3307
IC3308
IC3309
IC3656
IC3658
IC3663
IC3664
IC3665
IC3666
IC3783
IC3812
IC3888
IC3887
IC4068
IC4069
IC4257
IC4507
IC7578
IC3699
IC3700
Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump
UDI-DI
00813502011401
00813502012484
00813502012217
00813502012958
Serial number
IC8024
IC7912
IC8179
IC8216
IC8349
IC8415
IC8418
IC8529
IC8617
IC8808
IC8852
IC8906
IC9081
IC9082
IC9198
IC9227
IC9657
IC9987
IC10097
IC10098
IC10294
IC10327
IC10530
IC10531
IC10383
IC10578
IC10607
IC10549
IC10557
IC10717
IC10722
IC10769
IC10879
IC10877
IC10900
IC10926
IC11012
IC11068
IC11158
IC11168
IC11147
IC11203
IC11353
IC13018
IC13602
IC13606
IC13609
IC13610
IC13605
IC13498
All 293
IC13509
IC13506
IC13512
IC13514
IC13515
IC13517
IC13519
IC13513
IC13516
IC13534
IC13536
IC13537
IC13538
IC13535
IC13456
IC13495
IC13485
IC13575
IC13578
IC13551
IC13554
IC13548
IC13552
IC13553
IC13556
IC13558
IC13543
IC13549
IC13555
IC13559
IC13562
IC13564
IC13557
IC13563
IC13649
IC13651
IC13589
IC13591
IC13592
IC13598
IC13599
IC13600
IC13597
IC13593
IC13607
IC13608
IC13571
IC13572
IC13573
IC13596
IC13622
IC13620
IC13621
IC10025
IC9990
IC10240
IC10241
IC10592
IC10601
IC11198
IC11640
IC11642
IC11645
IC11646
IC13696
IC11123
IC11282
IC11264
IC11266
IC10146
IC10180
IC10371
IC10396
IC10397
IC10721
IC10772
IC10828
IC10835
IC11119
IC11072
IC11878
IC11958
IC11967
IC11969
IC11978
IC11986
IC11992
IC11997
IC12260
IC12261
IC12446
IC12454
IC12458
IC12459
IC12544
IC12546
IC12566
IC12586
IC12595
IC12596
IC12666
IC12670
IC12749
IC12744
IC12747
IC12768
IC10164
IC10165
IC12315
IC12318
IC9726
IC9730
IC9729
IC9830
IC10392
IC11217
IC11220
IC11215
IC11219
IC11281
IC11289
IC11952
IC11959
IC11960
IC11966
IC11970
IC11973
IC12309
IC12310
IC12307
IC12319
IC12455
IC12456
IC12467
IC12485
IC12484
IC10394
IC10400
IC10938
IC11715
IC11722
IC12220
IC12221
IC12671
IC12672
IC12561
IC12563
IC13338
IC13143
IC13144
IC13146
IC13148
IC13150
IC13151
IC13156
IC13157
IC13158
IC13142
IC8821
IC9076
IC9427
IC9766
IC10541
IC10639
IC12696
IC12700
IC12702
IC12703
IC12704
IC12753
IC12754
IC12755
IC12757
IC13281
IC10224
IC10225
IC10788
IC10789
IC10790
IC10792
IC10793
IC11723
IC11724
IC12256
IC13235
IC8836
IC8839
IC8902
IC9014
IC9022
IC10140
IC10141
IC10408
IC10425
IC10949
IC10954
IC10947
IC12320
IC12558
IC12568
IC12590
IC12597
IC12541
IC10560
IC10886
IC10892
IC10920
IC11074
IC11229
IC11998
IC12218
IC12288
IC12443
IC12444
IC12445
IC12452
IC12545
IC12552
IC12587
IC12762
IC10168
IC10125
IC11999
IC12278
IC12480
IC12543
IC12766
IC10312
IC11171
IC11172
IC12604
IC12605
IC12891
IC12895
IC12892
IC13266
IC13267
IC13503
IC13504
IC9399
IC9402
IC9626
IC10403
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump
UDI-DI
00813502010985
00813502010978
00813502010961
00813502011425
Serial number
IC6962
IC7004
IC7036
IC7170
IC7213
IC7214
IC7239
IC7241
IC7677
IC7787
IC7880
IC8105
IC8106
IC8295
IC8308
IC8315
IC8316
IC8335
IC8541
IC8543
IC11456
IC7937
IC9832
IC9833
IC5409
IC7798
IC7800
IC7946
IC8070
IC8337
IC8441
IC7825
IC8126
IC8630
IC8640
IC9804
IC11451
IC11497
IC8388
IC8751
IC9501
IC9989
IC10102
IC10103
IC10318
IC10589
IC10463
IC10979
IC11299
IC8164
All 179
IC9348
IC9500
IC9581
IC9648
IC9777
IC9793
IC9797
IC9915
IC9919
IC9922
IC10278
IC10302
IC10983
IC10984
IC10985
IC11174
IC11410
IC13231
IC13263
IC13264
IC13265
IC13681
IC13682
IC10040
IC10043
IC8401
IC8748
IC8980
IC8609
IC9178
IC9177
IC9324
IC9328
IC9557
IC9558
IC9744
IC9745
IC9746
IC9908
IC9921
IC9969
IC9970
IC10063
IC10064
IC10149
IC10150
IC10238
IC10239
IC10341
IC10366
IC10367
IC12407
IC12408
IC12409
IC13057
IC13060
IC13061
IC13064
IC8333
IC8494
IC12326
IC4952
IC5041
IC5158
IC5281
IC5283
IC5284
IC5403
IC5404
IC5413
IC5527
IC5588
IC5635
IC5636
IC5641
IC5643
IC5666
IC5667
IC5804
IC5805
IC5918
IC5921
IC6013
IC6343
IC6421
IC6422
IC6461
IC6463
IC6465
IC6777
IC6785
IC6944
IC6945
IC6946
IC7161
IC7233
IC7232
IC7235
IC7626
IC7738
IC7739
IC7792
IC7793
IC7826
IC7956
IC8012
IC8258
IC8423
IC8424
IC8499
IC8511
IC8723
IC8596
IC8665
IC8765
IC7827
IC7828
IC8404
IC11746
IC12344
IC12327
IC8426
IC13232
IC13698
IC7861
IC7862
IC8121
IC8222
IC8225

Recall details

Posted by FDA

Oct 28, 2026

Recall began

Sep 18, 2026

Status

Open

Weekly archive

Listed the week of Oct 26, 2026

Sold in

US (nationwide) and outside the U.S. to countries: Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom

Recalled by

Abiomed, Inc.Danvers, Massachusetts

Hazard

Software defect

Risk

High risk

There is a reasonable chance that using it could cause serious health problems or death.

FDA Class I recall · How risk is rated

FDA event number

99778

Recall numbers

Z-0208-2027 to Z-0210-2027

Recall type

Voluntary: Firm initiated

How the company first told customers

Letter

All recalls from Abiomed, Inc.

Timeline

FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.

Sep 18, 2026
Abiomed began the recall
Oct 28, 2026
FDA posted the recall to its Enforcement Report and rated it Class I (high risk)
Oct 29, 2026
Added to Recall Canary
Oct 31, 2026
Summary updated

What happened

What to do

Is yours affected?

Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump

Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump

Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump

Recall details

Timeline

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