Home › INTEGRA NEUROSCIENCES IMPLANT (FRANCE) › Radiopaque Polypropylene Plug

Radiopaque Polypropylene Plug

INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · Model 9MZ500 · UDI-DI 10381780035985

JXG Prescription

510(k) clearances

25,520

Adverse events (222 deaths)

108

Recalls

Facilities

Description

The Radiopaque Polypropylene Plug consists of a Tubing Plug provided for surgeons using the Integral Ventricular Reservoir (IVR) who prefer to use the wire introducer for introduction of the ventricular catheter. The plug allows to close the catheter after its placement.

Recalls

Date	Firm	Reason
2026-04-10	Integra LifeSciences Corp. (NeuroSciences)	Out-of-specification endotoxin result that did not meet the acceptance criteria.
2024-12-16	Integra LifeSciences Corp.	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-12-16	Integra LifeSciences Corp.	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-12-16	Integra LifeSciences Corp.	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-05-07	Integra LifeSciences Corp.	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
2024-05-07	Integra LifeSciences Corp.	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
2024-05-07	Integra LifeSciences Corp.	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
2023-11-28	Natus Medical Incorporated	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
2023-11-28	Natus Medical Incorporated	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
2023-06-28	Medtronic Neurosurgery	Product labeling contains incorrect expiration date

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.