Recalls / —
—#66371
Product
ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149
- FDA product code
- DSP — System, Balloon, Intra-Aortic And Control
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K965209
- Affected lot / code info
- 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
Why it was recalled
Leak may occur in the helium drive system for the IABP
Root cause (FDA determination)
Material/Component Contamination
Action the firm took
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.
Recalling firm
- Firm
- Arrow International Inc
- Address
- 2400 Bernville Rd, Reading, Pennsylvania 19605-9607
Distribution
- Distribution pattern
- 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, Mexico, Netherlands, New Zealand, Panama, Philippines, Portugal, Russia, Saudi Arabia, Italy, Spain, Sweden, Taiwan, and Turkey.
Timeline
- Recall initiated
- 2007-11-12
- Posted by FDA
- 2008-01-25
- Terminated
- 2010-01-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #66371. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.