Z-2425-2010

Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog...

Name: Z-2425-2010 Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog...
Creator: Integra LifeSciences Corp
Published: 2010-07-02
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2010-07-02 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp began a recall of Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10 on 2010-07-02. The reason FDA records is "Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2425-2010
Status: Terminated
Initiated: 2010-07-02
Posted: 2010-09-22
Terminated: 2012-05-29
Recalling firm: Integra LifeSciences Corporation
Product: Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10
Product code: HAO Instrument, Surgical, Non-Powered
Reason for recall: Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.
Root cause tag: manufacturing process
FDA 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 in commerce: 338 units
Distribution: Nationwide, Canada, Taiwan and to Integra, Australia.
Product codes and lots: Catalog number: 7CBD10, lot numbers: 1057983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, and 0161857.

Product code HAO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)