Z-0725-2021Class II

Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of...

Name: Z-0725-2021 Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of...
Creator: Integra LifeSciences Corp.
Published: 2020-12-14
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2020-12-14 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the... on 2020-12-14. FDA classified it as Class II and gives the reason as "Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0725-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-14
Posted: 2020-12-23
Terminated: 2021-07-19
Recalling firm: Integra LifeSciences Corporation
Product: Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Integra Lifesciences notified consignees (Hospitals and Sales Representatives ) by Urgent Medical Device Recall letter between December 14 and 16, 2020 via courier service, facsimile or email about the initial notification between December 14 and 16, 2020. Letter state reason for recall, health risk and action to take: Customers a. If you do have the affected product in Table 1, remove the product from service. b. Complete the attached acknowledgement form. If you do have affected product, check the box I do have affected product. Record the total quantity of the affected product you have. c. If you do not have affected product, check the box, I do not have affected product. d. Return the completed acknowledgement form to [email protected] or FAX to 1-609-750-4220 e. Keep a copy of the form for your records. f. When your form is received, and it is noted that you have the affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the product. A replacement order will also be placed for the quantity noted on the form. Questions regarding these instructions, please contact Customer Service: USA: 800-654-2873 Monday- Friday 8:00AM EST 6:00PM EST [email protected]
Quantity in commerce: 17 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Number:4178257 Exp. Date: November 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0725-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0724-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23
Z-0725-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23

Product code JXG

K110751Class IICodman Bactiseal Endoscopic Venticular CatheterCodman & Shurtleff, Inc. / cleared 2011-05-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)