CLASS I Device recall · Reported 29 May 2019 · FDA Enforcement Report
LimiTorr INS9020 Ins-9020 Limitorr Volume Limiting Evd recalled
Integra LifeSciences is recalling LimiTorr INS9020 Ins-9020 Limitorr Volume Limiting Evd LimiTorr INS9020SP1 Ins-9020SP1, distributed nationwide in the US. The recall was initiated on 8 Apr 2019 and the FDA has classified it as Class I.
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-1312-2019
- FDA event ID
- 82659
- Recalling firm
- Integra LifeSciences, Plainsboro, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 Apr 2019
- FDA classified
- 20 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 8 Apr 2019 | Recall initiated by company | |
| 20 May 2019 | Classified by FDA | +42 days |
| 29 May 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The LimiTorr External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached. Indications: The LimiTorr system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and to monitor ICP.
Where it was distributed
Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.
Questions about this recall
Why was it recalled?
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Which lots are affected?
All lots
Where was it sold?
Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 82659This product is part of a recall event; the main page for the event is MoniTorr INS1100 INS-1100 CSF Drainage System used recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | MoniTorr INS1100 INS-1100 CSF Drainage System used recalled | Integra LifeSciences | Device Malfunction | Nationwide | |
| CLASS I | MoniTorr 10100 10-100 CSF Drainage System w/Patient Line recalled | Integra LifeSciences | Device Malfunction | Nationwide |
More recalls from Integra LifeSciences
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|---|---|---|---|---|---|
| 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 Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |