Medical Devices
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 Measurement System
This recall notice has been updated.
Please see the recalled dated January 26, 2011 to see the most current information.
This prior version remains on the website for historical purposes.
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:
- Arrow International Urgent Medical Device Recall
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
