ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149
Hazard
Leak may occur in the helium drive system for the IABP
What You Should Do
Remedy
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.
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Products
ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149
- Brand
- Arrow International Inc
- UPC
- SERIAL NOS: 070511A, 070512A, 070513A, 070514A, 070515A, 070516A, 070517A, 070518A, 070519A, 070520A, 070521A, 070522A, 070523A, 070524A, 070525A, 070601A, 070602A, 070603A, 070604A, 070605A, 10708A, 70206A, 70207A, 70208A, 70209A, 70210A, 70301A, 70302A, 70303A, 70304A, 70305A, 70401A, 70402A, 70403A, 70404A, 70405A, 70501A, 70502A, 70503A, 70504A, 70505A, 70506A, 70507A, 70508A, 70509A, 70510A, and 90305A
Units Affected
47 units