FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp: Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10
- Recall number
- Z-2425-2010
- Recalling firm
- Integra LifeSciences Corp
- Product
- Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10
- Status
- Terminated
- Initiated
- 2010-07-02
- Posted
- 2010-09-22
- Terminated
- 2012-05-29
- Reason
- Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.
- Root cause
- 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
- 338 units
- Distribution
- Nationwide, Canada, Taiwan and to Integra, Australia.
- Lot, serial or model codes
- Catalog number: 7CBD10, lot numbers: 1057983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, and 0161857.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HAO
- Firm FEI
- 1121308
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28