Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ACAT 1 Series

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ACAT 1 Seriessee related information
Date Initiated by FirmNovember 12, 2007
Date PostedJanuary 25, 2008
Recall Status1 Terminated 3 on January 11, 2010
Recall NumberZ-0549-2008
Recall Event ID 45871
510(K)NumberK965209 
Product Classification Intra-Aortic Balloon and Control System - Product Code DSP
ProductACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149
Code Information 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 
FEI Number 3015859709
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactMike Neibert, Director Global Tech Servi
800-447-4227
Manufacturer Reason
for Recall		Leak may occur in the helium drive system for the IABP
FDA Determined
Cause 2		Material/Component Contamination
ActionArrow 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 in Commerce47 units
DistributionWorldwide- 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DSP
-
-