ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149
FDA device recall Z-0549-2008 · posted 2008-01-25 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Leak may occur in the helium drive system for the IABP
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 47 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, Co
- Date initiated
- 2007-11-12
- Date posted
- 2008-01-25
- Date terminated
- 2010-01-11
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) (K965209) | Arrow Intl., Inc. | 1998-01-23 |