Integra Recalls Mislabeled Bactiseal Endoscopic Ventricular Catheters
Integra LifeSciences is recalling 17 Bactiseal Endoscopic Ventricular Catheters due to mislabeling. The devices were incorrectly identified as a different catheter model.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Integra LifeSciences Corp. is recalling 17 units of the Bactiseal Endoscopic Ventricular Catheter (Part Number 823087). The recall is due to a labeling error where the product was mislabeled as the Bactiseal Ventricular Catheter with Bactiseal Shunt System (Part Number 823073), and vice versa.
The affected units are identified by Lot Number 4178257 and have an expiration date of November 2019. The distribution was nationwide across the United States. These catheters are designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid from the ventricles of the brain.
Healthcare providers and patients should verify the specific part number of the device in use. If the device matches the recalled part number and lot information, it should be removed from service and returned to the manufacturer or distributor according to their instructions.
The recalled product
- 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
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Neurological
- Hazard
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number:4178257 Exp. Date: November 2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
Same hazard · mis labeling
See all →- HighByron White Herbal Supplement Recalled for Undeclared Walnut Allergen
FDA (Food) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02