Arrow International Inc ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149
Brand
Arrow International Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Arrow International Inc is recalling ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149 due to Leak may occur in the helium drive system for the IABP. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Leak may occur in the helium drive system for the IABP
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, IN, KS, MA, MO, NV, NY, PA, SC, TN, TX, WA
Page updated: Jan 10, 2026