Recall Z-0550-2008 ยท DSP System, Balloon, Intra-Aortic And Control
Arrow International Inc
AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Arrow International, Everett, MA 02149
| Date | Jan 25, 2008 (initiated Nov 12, 2007) |
| Status | Terminated |
| Reason | Leak may occur in the helium drive system for the IABP |
| Root cause | Material/Component Contamination |
| Action | Arrow International notified customers by letter dated November, 2007 titled: Urgent Medical Device Field Correction. Customers are instructed to follow the Recommended Action included in the letter while awaiting replacement of the defective component to be performed by service representative. |
| Quantity | 225 units |
| Distribution | Worldwide- USA, including the states of CA, CO, FL, IN, KS, MA, MO, NV, NY, PA, SC, TN, TX, and WA and countries of Canada, Africa, Argentina, Austria, Bangladesh, Belarus, Belgium, Brazil, Canada, Columbia, Czech Rep, UK, Finland, France, Germany, Hungary, India, Indonesia, Italy, Japan, Korea, Mex |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060309 | AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES Arrow Intl., Inc., Apr 6, 2006 |