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U.S. Department of Health and Human Services

Class 2 Device Recall SteeroCathDx Diagnostic Catheter

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 Class 2 Device Recall SteeroCathDx Diagnostic Cathetersee related information
Date Initiated by FirmFebruary 14, 2008
Date PostedAugust 30, 2008
Recall Status1 Terminated 3 on January 08, 2011
Recall NumberZ-1618-2008
Recall Event ID 47388
Product Classification Cardiac Catheter - Product Code DRF
ProductBoston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter
Code Information Model Numbers M0042027BL0 (Lot#: 0011092878, 0011092882, 0011107097) and M0042028BL0 (Lot#: 0011036506, 0011036507, 0011036585, 0011036586, 0011043535, 0011043537, 0011046910, 0011046913, 0011049772, 0011049773, 0011054879, 0011055000, 0011059409, 0011059410, 0011061991, 0011061992, 0011065023, 0011065024, 0011069509, 0011069510, 0011073729, 0011073730, 0011078604, 0011078605, 0011081318, 0011081445, 0011083742, 0011083743, 0011087354, 0011087355, 0011088108, 0011088109, 0011096360)
FEI Number 3001236349
Recalling Firm/
Manufacturer		 Boston Scientific Corp
150 Baytech Drive
San Jose CA 95134
For Additional Information Contact
408-935-3400
Manufacturer Reason
for Recall		Package sterile barrier may be breached, compromising sterility.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionRecall initiated on Feb. 14, 2008, via Urgent Medical Device Recall notification being sent to consignees, along with a reply verification tracking form. If you have questions or need a copy of the recall notification, contact Deborah J. Springer at 1-408-935-4944 or springed@bsci.com.
Quantity in Commerce827 units total
DistributionWorldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
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.
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