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Cyst Puncture Catheter

INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · Model 9ME617 · UDI-DI 10381780035787

JXG Prescription

510(k) clearances

25,592

Adverse events (226 deaths)

108

Recalls

Facilities

Description

The Cyst Puncture Catheter is a 25 cm long, radiopaque silicone elastomer catheter with a tapered end terminating in a tip with a hole. The catheter features radiopaque length markings at 5, 10 and 15 cm from the tip. The catheter has 4 drainage holes, 180 degrees apart. The proximity of the holes near the tip ensures that the holes will not extend outside small cysts. Each catheter is supplied with 2 stylets: a blunt-ended stylet and a sharp-ended stylet.

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 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.
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

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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.