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Class I Medical Device Recall: Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-

Posted Dec 29 2010 12:00am

Recall Class: Class I

Date Recall Initiated: October 11, 2010

Products:
Arrow IAB (Intra Aortic Balloon), Ultra 8 Fr, 30cc
Arrow IAB (Intra Aortic Balloon), Ultra 8 Fr, 40cc
Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System, 30cc
Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System, 40cc

Manufacturing From: January 2009 to October 2010

Distribution From: November 2009 to October 2010

The following model and lot numbers affected can be found using the following List Number Configurations:

Model Number - Country /
Language Code - Inventory Code
Lot Number - Country /
Language Code - Inventory Code
IAB-05830-U KF0087756
MF9014573
MF9025207
MF9025208
MF9025213
MF9025226
MF9025227
MF9035382
MF9035448
MF9088501
MF9099356
MF9099357
MF9099358
MF9099359
MF9110054
MS9057152
MS9057153
MS9109664
MS9110295
MS9110368
MF9067735
MF9067736
MF9077955
MF9077968
MF9077969
MF9078203
MF9078343
MF0053017
MF0053018
MF0053019
MF0073778
MF0074136
MF0074137
MS9056710
IAB-05840-U KF0087855
KF0087856
MF9014575
MF9014817
MF9024965
MF9024993
MF9025112
MF9025209
MF9035509
MF9035685
MF9088685
MF9100025
MS9056857
MS9057154
MS9110263
MS9110269
MS0053114
MF9035955
MF9046057
MF9046247
MF9046501
MF9056746
MF9057069
MF9057070
MF0011189
MF0021654
MF0042406
MF0042501
MF0042786
MF9067275
MF9067738
MF9077954
MF9078048
MF9078052
MF9078348
MF9078349
MF0053023
MF0063353
MF0073903
MF0074071
MS9056684
IAB-05830-LWS KF0097980
KF0097981
KF0097982
MF9025252
MF9025253
MF9025254
MF9025255
MF9025320
MF9025322
MF9035383
MF9035385
MF9035611
MF9035612
MF9088679
MF9088680
MF9099229
MF9099230
MF9099231
MF9099232
MF9099233
MF9099310
MF9099353
MF9100006
MF9100007
MF9109757
MF9109758
MF9110055
MF9110192
MF9110303
MF9110304
MF9110305
MS9056811
MS9109705
MS9109708
MF9035835
MF9035954
MF9056741
MF9056846
MF9057067
MF9057068
MF0011388
MF0021613
MF0021614
MF0021615
MF0021616
MF0031841
MF0031842
MF0032167
MF0042783
MF0042784
MF0042785
MF9067348
MF9067349
MF9067737
MF9077887
MF9077970
MF9077972
MF9078195
MF9078196
MF9078197
MF9078198
MF9078200
MF9078344
MF9078345
MF9078346
MF9078347
MF0053022
MF0063352
MF0073779
MF0073902
MF0074070
MS9056709
MS9056810
IAB-05840-LWS KF0087765
KF0087766
KF0087857
KF0087858
MF9014819
MF9024960
MF9025107
MF9025108
MF9025109
MF9025110
MF9025111
MF9025117
MF9025118
MF9025145
MF9025158
MF9025166
MF9025167
MF9025210
MF9035386
MF9035449
MF9035450
MF9035451
MF9035613
MF9035614
MF9035695
MF9078364
MF9088681
MF9088682
MF9088683
MF9088684
MF9088779
MF9088780
MF9099197
MF9099198
MF9099199
MF9099311
MF9099312
MF9099354
MF9099355
MF9109756
MF9109824
MF9109825
MF9109970
MF9110191
MF9110244
MF9110245
MF9110300
MF9110301
MF9110520
MF9110521
MF9120677
MF9120678
MF9120749
MF0010929
MF0010930
MF0010931
MS9056853
MS9056854
MS9056855
MS9109707
MS9109709
MF9035696
MF9035697
MF9035698
MF9035748
MF9035836
MF9035837
MF9035957
MF9035958
MF9046058
MF9040696
MF9046097
MF9046203
MF9046204
MF9046205
MF9046243
MF9046403
MF9046404
MF9046405
MF9046404
MF9046407
MF9046502
MF9046548
MF9046549
MF9046550
MF9046551
MF9056744
MF9056745
MF9056847
MF9056848
MF9056936
MF9056937
MF9056938
MF9056939
MF9056940
MF9057071
MF9057072
MF9057171
MF9067269
MF9067270
MF0010932
MF0011098
MF0011099
MF0011184
MF0011185
MF0011327
MF0011328
MF0011329
MF0021481
MF0021482
MF0021582
MF0021583
MF0021584
MF0021585
MF0021655
MF0021656
MF0031800
MF0031801
MF0031802
MF0031920
MF0032013
MF0032014
MF0032015
MF0032113
MF0032114
MF0042360
MF0042361
MF0042393
MF0042394
MF0042395
MF0042502
MF0042503
MF0042779
MF0042780
MF0042781
MF0042782
MF0053006
MF0053007
MF0053008
MF0053009
MF9067271
MF9067272
MF9067273
MF9067332
MF9067350
MF9067351
MF9067487
MF9067488
MF9067575
MF9067576
MF9067577
MF9067631
MF9067739
MF9067740
MF9067741
MF9067742
MF9077888
MF9077889
MF9077890
MF9077893
MF9078350
MF9078351
MF9078352
MF9078353
MF9078354
MF9078361
MF9078362
MF9078363
MF0053233
MF0053234
MF0063366
MF0063368
MF0063419
MF0063420
MF0063441
MF0063472
MF0063594
MF0063595
MF0073845
MF0073846
MF0073847
MF0073848
MF0073850
MF0073851
MF0073852
MF0073853
MF0073854
MF0073855
MF0073586
MF0073955
MF0073956
MF0074046
MF0074047
MF0074072
MF0074130
MF0074131
MF0074132
MF0074133
MF0074134
MS9046468
MS9046478
MS9046479
MS9056585
MS9056586
MS9056679
MS9056707

Use: The Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System are used in the treatment of a variety of cardiac conditions, including heart failure, septic shock, and myocardial infarction. They are also used to support and stabilize high-risk patients undergoing diagnostic and non-surgical procedures.

Recalling Firm:

Arrow International, Inc.,
Division of Teleflex Medical Inc.
9 Plymouth Street
Everett, Massachusetts 02149-1814

Reason for Recall: The IAB catheters can become stuck in the sheath. When the IAB catheter becomes stuck, the user is unable to move the IAB catheter forward or backward, causing delay in therapy, bleeding or arterial injury.

Public Contact: Michael A. Douglass, Director of Quality Assurance at 617-389-6400

FDA District: New England

FDA Comments:

Arrow International is advising customers to immediately discontinue use of any affected products and contact Arrow Customer Service at 866-396-2111.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experience using these products to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.

Useful Links:

    
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