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  5. lntegra LifeSciences Recalls the LimiTorr Volume Limiting CSF Drainage System and the MoniTorr ICP External CSF Drainage and Monitoring System Due to Possible Breakage of the LimiTorr Transducer and MoniTorr Panel Mount Stopcock
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lntegra LifeSciences Recalls the LimiTorr Volume Limiting CSF Drainage System and the MoniTorr ICP External CSF Drainage and Monitoring System Due to Possible Breakage of the LimiTorr Transducer and MoniTorr Panel Mount Stopcock

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems
  • Catalog Number: See full list below
  • Manufacturing Dates: March 1, 2017 to March 31, 2019
  • Distribution Dates: March 1, 2017 to March 31, 2019
  • Devices Recalled in the U.S.: 24,587
  • Date Initiated by Firm: April 8, 2019

Device Use

The LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems are used by health care providers to monitor pressure inside the skull (intracranial pressure) and to drain CSF from the brain to reduce intracranial pressure or provide temporary drainage of CSF in patients with infected CSF shunts and to monitor ICP.  The devices can also be used for controlled drainage of CSF from the lumbar subarachnoid space.

Reason for Recall

lntegra LifeSciences is recalling the LimiTorr & MoniTorr Drainage Systems due to reported complaints regarding: “piece breaking off at connection point,” “broken manifold-stopcock,” “stopcock problem,” “connection where the external transducer is attached to the transducer holder bracket broke off,” and “transducer attachment on the LimiTorr/MoniTorr has cracked and was leaking CSF.” This breakage occurs when there is over-bending of the stopcock most often related to the use of LimiTorr or MoniTorr in combination with a Fluid Filled Transducer.

The device failure could result in infection (meningitis or ventriculitis), fever, headache, over drainage leading to subdural hematoma, over-drainage leading to the shifting of brain tissue (herniation), backflow of air leading to a condition in which air or gas is trapped within the intracranial cavity (pneumocephalus), or death.

Serious patient injuries associated with infection and CSF leakage (over-drainage) related to the failure mode associated with this recall were reported. There were no deaths reported.

Who May Be Affected

  • Patients undergoing procedures involving the LimiTorr and MoniTorr Drainage Systems
  • Healthcare professionals and distributors who use the LimiTorr and MoniTorr Drainage Systems

What to Do

lntegra LifeSciences issued an initial Urgent Recall Notification on April 8, 2019. On May 15, 2019, the Urgent Recall Notification was corrected to inform customers and distributors to:

  • NOT CONNECT a Fluid Filled Transducer directly to the products listed on the notification.
  • NOT USE LimiTorr and MoniTorr Drainage Systems for patients requiring ventricular CSF drainage or any use in which a Fluid Filled Transducer must be directly connected to the device for pressure monitoring.
  • Carefully inspect the LimiTorr Transducer Mount stopcock and the MoniTorr Panel Mount stopcock during usage for any signs of cracking of the device.

Integra LifeSciences also recommended the following actions:

Customers

  • Review your inventory and determine if you have any catalog numbers listed on the notification.
  • Once identified, please DO NOT DIRECTLY CONNECT these devices in conjunction with a Fluid Filled Transducer.
  • DO NOT USE this product for patients requiring ventricular CSF drainage or any use in which a Fluid Filled Transducer must be directly connected to the device for pressure monitoring.
  • Complete the “Acknowledgement Form” and return the completed form to FCA1@integralife.com or FAX to 1-609-750-4220.
     indicating receipt and review of this notification. Keep a copy of the form for your records.
  • Integra sales representatives will provide additional product labels to apply to the current inventory at your location.

Distributors

  • Review your inventory and determine if you have any catalog numbers listed on the notification.
  • Once identified, we recommend you review and understand the information provided in this Field Safety Correction.
  • Please check your customer traceability records for shipments of above catalog numbers.
  • Complete the attached “Acknowledgement Form” and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records.
  • Forward a copy of the enclosed Field Safety Correction to any of your customers that have purchased the above catalog numbers.
  • Keep a copy of the notification and signed copy of the Acknowledgement Form for your records.

Integra LifeSciences will also provide distributors with additional product labels to apply to the current inventory at their location.

How to Recognize that the Device may Fail

  • There may be a cracking sound if the stopcock is over-tightened.
  • The attached transducer may become loose.
  • There may be signs of visible cracking of the stopcock.
  • There may be signs of CSF leakage at the junction of the stopcock and the transducer or at the junction of the stopcock and the manifold.
  • There may be a dampened or irregular ICP waveform when obtaining ICP readings.

Contact Information

Customers who have questions or need additional information or support regarding this recall should contact lntegra LifeSciences Customer Service at 1-800-654-2873 or email: custsvcnj@integralife.com

How do I Report a Problem

Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

More Information

FDA Medical Recall Database Class 1 Recall MoniTorr

Catalog Number Catalog Description UDI-DI
10-100 CSF Drainage System w/Patient Line One Way Valve 10381780070825
10-102 CSF Drainage System w/Patient Line One Way Valve w 10381780070832
10-110 CSF Drainage System used with Pole Mount System 10381780070849
10-140 CSF Drainage System w/Vinyl Measuring Strip 10381780070856
10-150 CSF Drainage System Simple Bag and Line 10381780070887
10-150 CSF Drainage System w/o Manifold Stopcock 10381780070894
INS-1100 CSF Drainage System used with Pole Mount System 10381780071037
INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML 10381780071105
INS- 9020SP1 LIMITORR VOLUME EVD 20ML 10381780071112
INS- 9020SP1 LIMITORR VOLUME LIMITING EVD 30 ML 10381780071129
INS- 9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML 10381780071136
SP0017 Special EVD 10-110 w/o Y Site Latex Free Sites 10381780071891
SP0042 Special EVD 10-100 w/o Y Site 10381780071914
SP0090 Special EVD 10-110 w/o Y Site 10381780071921
SP0164 Special EVD 10-140 w/Y Site & Stopcock Reverse 10381780071945
SP0236 INS 1100 WITH NEEDLE AT Y-ACCESS AND NEEDLELESS SI 10381780072560