This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
The FDA is aware that J&J MedTech and their subsidiary, CERENOVUS Inc., have issued a letter to affected customers recommending certain CEREPAK products be removed from where they are used or sold. Affected devices:
- CEREPAK Uniform Detachable Coil System
- CEREPAK Uniform XL Detachable Coil System
- CEREPAK Uniform 3D Detachable Coil System
- CEREPAK Heliform Soft Detachable Coil System
- CEREPAK Heliform XtraSoft Detachable Coil System
- CEREPAK Heliform XL Detachable Coil System
- CEREPAK Heliform XtraSoft XL Detachable Coil System
- CEREPAK Freeform Detachable Coil System
- CEREPAK Freeform Mini Detachable Coil System
- CEREPAK Freeform XtraSoft Detachable Coil System
What to Do
Do not use affected product. Identify and segregate all affected devices that are in inventory or consignment at your facility.
On October 2, 2025, J&J MedTech sent all affected customers a letter recommending the following actions:
- Immediately stop using the affected devices.
- Identify and segregate all affected devices that are in inventory or consignment at your facility.
- Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed.
- If any product subject to this recall has been forwarded to another facility, contact that facility, provide a copy of this letter, and notify J&J sales representative.
- If the product has been successfully implanted, there is no additional action needed.
- Keep the provided notice visibly posted for awareness until all product subject to this recall have been returned. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records.
- There is currently no estimated date for CEREPAK Detachable Coil Systems to be available again in the market, J&J sales representatives can support in identifying alternative J&J products.
Reason for Recall
J&J MedTech is removing CEREPAK Detachable Coil Systems due to a higher-than-expected failure to detach rate. The failure to detach could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
As of October 14, 2025, J&J MedTech has reported four serious injuries and one death associated with this issue.
Device Use
The CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, and Freeform Mini Detachable Coil Systems are indicated for embolization of intracranial aneurysms, neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature. The CEREPAK Freeform XtraSoft Detachable Coil System is indicated for embolization of intracranial aneurysms.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact J&J Medtech (CERENOVUS Inc.) at OneMD-Field-Actions@its.jnj.com.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
