Vascular Cannula Recall: Medtronic Removes Aortic Root Cannula Due to Unexpected Loose Material in the Male Luer

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

Product Names:
- DLP Aortic Root Cannula
- MiAR Cannula
- DLP Aortic Root Cannula with Vent Line
Unique Device Identifier (UDI)/Model:
- DLP Aortic Root Cannula
  - 20613994495451/11012
  - 20613994495482/11014
- MiAR Cannula
  - 20613994495468/11012L
  - 20613994495499/11014L
- DLP Aortic Root Cannula with Vent Line
  - 20613994495390/21012
  - 20613994495406/21014
Lot Numbers: See Full List of Affected Devices below

What to Do

Do not use any unused Aortic Root Cannulas from affected lots.

On February 5, 2025, Medtronic sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:

For Health Care Providers

Monitor patients who were previously supported using this device according to your normal follow-up procedures. There are no additional risks to patients who previously received support using an impacted device.

For Health Care Facilities

Review inventory for affected product lots.
Identify and quarantine all unused affected product.
Contact Medtronic Customer Service Return at 1-800-854-3570, Option 1 then Option 4, to arrange for return of unused affected product and credit.
- The facility’s Medtronic sales representative can help with the return process as needed.
Complete the Customer Confirmation Form and send by email to RS.CFQFCA@medtronic.com, even if there is no affected product at the facility.
Share the notification with others at the facility and with other facilities who may have received affected product from your facility.
Keep a copy of the letter for facility records.

Reason for Recall

Medtronic is recalling Aortic Root Cannulas due to the risk for unexpected loose material in the male luer used in the cannula. The loose material has the potential to become dislodged and cause serious patient adverse health consequences, including injuries caused by delayed therapy, stroke, and death.

There have been no reported injuries and no reports of death.

Device Use

Aortic Root Cannulas are used for six hours or less during surgery with the heart-and-lung machine (cardiopulmonary bypass) . The cannula may also be used to remove air from the major artery (aorta) when a bypass procedure is finished.

Contact Information

Customers in the U.S. with questions about this recall should contact their Medtronic field representative or Customer Service at 1-800-854-3570.

Full List of Affected Devices

2022020438
2022030157
2022030297
2022030478
2022030747
2022040309
2022040902
2022050053
2022050697
2022050698
2022060347
2022061333
2022070054
2022070055
2022081070
2022081428
202209C071
202211C054
2023020719
2023020720
2023030372
2023031531
2023040161
2023040433
2023040806
2023041172
2023050066
202305C067
202307C101
2023100087
2023100234
2023100235
2023100489
2023100490
2023100876
2023111145
2023111146
2023120073
2023120484
2023120485
202312C018
2024011341
2024011342
2024011344
202401C303
202401C304
2024020238
202402C163
2024030255
2024030256
2024030692
2024040471
2024040472
2024040473
2024040474
2024040475
2024040476
2024040575
2024051027
2024051028
2024051029
2024060711
2024060712
202406C113
202406C114
202407C087
2024100440
2024100441

2022010949
2022020094
2022020439
2022020440
2022031296
2022050367
2022050702
2022060276
202206C093
2022070409
2022070410
2022070411
2022070840
2022070841
2022071072
202207C093
2022080418
2022080815
2022081073
202209C066
2022110377
2022110378
2022110379
202301C158
202301C159
2023020394
2023040163
2023040435
2023040809
2023041174
2023041175
2023050068
2023050394
2023050395
2023050396
2023050790
2023051166
2023051167
202305C077
2023060413
2023060414
2023060416
2023060417
2023061123
2023061124
2023061125
2023061126
2023061327
202306C142
202306C143
202307C098
202307C099
2023080113
2023080115
2023080116
2023080118
2023080720
2023080721
2023080722
2023080724
202308C215
2023111148
2024010350
2024010351
2024010419
2024010566
2024010907
2024010908
202402C164
2024030495
2024030496
2024030693
2024030694
2024030695
2024030696
2024030964
2024030965
2024040576
2024040577
2024040807
2024050923
2024050924
202405C078
202405C088
2024060413
2024060414
2024060415
2024060416
2024071241
202407C089
202407C090
202409C108
202308C214

2022010947
2022020079
2022020081
2022020084
2022030745
2022030989
2022031294
2022040135
2022040136
2022040308
2022060274
2022070048
2022070049
2022070050
2022070051
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2022080060
2022080414
2022090111
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2022090114
2022090828
202209C072
202209C083
202211C036
2023021125
2023021126
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2023021128
2023021129
202304C091
2023070452
2023070455
2023070456
2023070457
2023070458
2023070461
2023070466
2023070954
2023070955
2023070956
2023070957
2023070958
2023070959
2023070960
2023070961
2023070962
2023070963
202308C216
202308C217
202310C187
2023110161
2023111071
2023111072
2023111073
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2023111279
2023111280
2023111644
2023111645
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202312C209
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2024040044
2024050060
202405C075
202405C076
202406C128
2024070439
2024070499
2024070501
2024080674
2024100439

2022010948
2022020086
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2022020091
2022030298
2022030479
2022030748
2022030990
2022031295
2022040310
2022050699
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2022050701
2022060275
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2022070408
202207C105
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2022081071
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202209C075
2022100740
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2022110052
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2022110057
2022110714
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202211C037
202301C133
202301C164
2023020721
2023020722
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2023020724
2023021130
2023021131
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2023030373
2023030374
2023031532
202303C270
202303C272
2023040162
2023040434
2023040807
2023040808
2023041173
2023050067
2023050391
2023050392
2023050393
2023050788
2023051165
202305C076
2023060113
2023060115
2023060116
2023060119
2023060120
2023060233
2023061326
202306C138
202306C140
202307C100
2023101327
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2023101351
2023110217
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2023120163
2023120165
2023121023
202312C210
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202401C028
202401C029
2024020443
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2024020799
2024030344
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2024030346
2024030805
2024030807
2024030981
2024030982
202403C067
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2024050386
2024050387
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2024050753
202405C077
202406C112
2024070502
2024070503
2024070504
2024070505
2024070746
2024070747
202407C088
2024100985
2024100986
2024100987

2022011031
2022020476
2022020860
2022030187
2022030188
2022030342
2022030509
2022030796
2022040355
2022040942
2022050019
2022050095
2022050399
2022051040
2022051041
2022060388
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2022060761
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2022061357
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202206C139
202207C140
2022080099
2022080100
2022081112
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2022081450
2022081451
2022081452
202209C146
202209C149
202301C214
2023020764
2023020765
2023021173
2023021174
2023030170
2023030171
2023030407
2023030971
2023031039
2023031040
2023031041
2023031555
2023031556
2023031557
2023040199
2023040200
2023040201
2023040470
2023040471
2023040851
2023041219
2023041220
202304C103
2023050113
2023050114
202305C119
202305C120
202305C121
202306C184
2023070519
2023100245
2023100246
2023100511
2023100512
2023100896
2023100897
2023110464
2023110465
2023110467
2023110944
2023111164
2023111165
2023120093
2023120094
2023120095
2023120096
2023120097
2023120505
202312C034
202312C035
2024011374
2024011375
2024011377
2024011378
202401C104
202401C136
2024020259
2024020260
2024030275
2024030276
2024030277
2024030278
2024030279
2024030502
2024030503
2024030504
202403C129
202403C130
2024040485
2024040486
2024040596
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202405C115
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2024060539
2024070226
2024070519
2024080125
2024080390
2024080929
2024080930
202408C046
202408C047
202410C025
202410C026

2022011033
2022011174
2022020477
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2022020862
2022030343
2022030973
2022031019
2022031322
2022040356
2022040943
2022050026
2022050096
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2022051042
202205C067
2022060390
2022061078
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202206C140
2022070457
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202207C141
2022080101
2022080102
2022080456
2022080952
202209C168
202209C171
2022110406
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202303C309
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2023040852
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2023050115
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2023050435
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2023050861
2023050862
2023050865
202305C122
2023060162
2023060163
2023060465
2023060466
2023061168
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2023061390
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202306C185
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202306C187
202307C133
202307C135
2023080188
2023080190
2023080723
202309C018
2023111166
2023111167
2024010335
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2024010998
202403C131
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2024040598
2024040823
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2024050941
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2024051288
2024060291
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202406C117
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2024070994
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202408C049
2024090331
2024090658
2024090936
2024100069
2024100070
2024100071
2024100072
2024101042
202410C027

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.