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U.S. Department of Health and Human Services

Class 1 Device Recall NeuroBalloon

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  Class 1 Device Recall NeuroBalloon see related information
Date Initiated by Firm July 02, 2010
Date Posted September 22, 2010
Recall Status1 Terminated 3 on May 29, 2012
Recall Number Z-2425-2010
Recall Event ID 56190
Product Classification neurovascular catheter - Product Code HAO
Product Integra NeuroSciences Implants, NeuroBalloon Catheter,
Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10
Code Information Catalog number: 7CBD10, lot numbers: 1057983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, and 0161857.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp
105 Morgan Ln
Plainsboro NJ 08536-3339
For Additional Information Contact James Tillman
609-936-2485
Manufacturer Reason
for Recall		 Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.
FDA Determined
Cause 2		 Process design
Action All customers and Integra Sales Specialists were notified of the recall on July 2, 2010 by fax, e-mail and letter send by Fed Ex overnight delivery.
Quantity in Commerce 338 units
Distribution Nationwide, Canada, Taiwan and to Integra, Australia.
Total Product Life Cycle TPLC 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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