CLASS II ONGOING Device recall · Reported 19 Jun 2024 · FDA Enforcement Report
Codman Bactiseal Evd Catheter Set - Indicated recalled
Integra LifeSciences is recalling Codman Bactiseal Evd Catheter Set - Indicated for gaining access to the ventricles of the, distributed nationwide in the US. The recall was initiated on 7 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2136-2024
- FDA event ID
- 94622
- Recalling firm
- Integra LifeSciences, Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 May 2024
- FDA classified
- 12 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 May 2024 | Recall initiated by company | |
| 12 Jun 2024 | Classified by FDA | +36 days |
| 19 Jun 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821745
Where it was distributed
Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey
Questions about this recall
Why was it recalled?
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
Which lots are affected?
UDI-DI: 10381780515593 Lot numbers: 7320001, 7320004, 720005, 7322926, 322927
Where was it sold?
Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 94622| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Codman Bactiseal Clear Evd Catheter I.D recalled by Integra LifeSciences | Integra LifeSciences | Sterility | Nationwide | |
| CLASS II | Codman Evd Bactiseal I.d recalled by Integra LifeSciences | Integra LifeSciences | Sterility | Nationwide |
More recalls from Integra LifeSciences
All 246| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Aurora Surgiscope System, Sterile recalled by Integra LifeSciences | Integra LifeSciences | Device Malfunction | Nationwide |
| Device | CLASS II | MediHoney¿ Gel MediHoney¿ Wound & Burn Dressing Gel recalled | Integra LifeSciences | Packaging Defects | Nationwide |
| Device | CLASS II | Codman Certas Plus Programmable Valve Inline Small Valve Only recalled | Integra LifeSciences | Packaging Defects | Nationwide |
| Device | CLASS II | Codman Certas Plus Programmable Valve Right Angle Valve Only recalled | Integra LifeSciences | Packaging Defects | Nationwide |
| Device | CLASS II | Codman Certas Plus Programmable Valve Inline Small Valve Only recalled | Integra LifeSciences | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |