Recall archive
10 recalls · page 1 of 1
Reported Jun 3, 2015
CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Codman & Shurtleff, Inc.
Matched: Brand · Product · Product details — Needle is leaking from hub/needle cannula connection
FDA (openFDA device enforcement)
Reported Oct 29, 2014
Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Codman & Shurtleff, Inc.
Matched: Brand · Product · Product details — tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2014
Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Codman & Shurtleff, Inc.
Matched: Brand · Product · Product details · Reason for recall — To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
7 more products in this recall
FDA (openFDA device enforcement)
Reported May 21, 2014
MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Codman & Shurtleff, Inc.
Matched: Brand — A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2014
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Codman & Shurtleff, Inc.
Matched: Brand · Product · Product details · Reason for recall — Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted…
FDA (openFDA device enforcement)
Reported Feb 5, 2014
Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Codman & Shurtleff, Inc.
Matched: Brand · Product · Product details · Reason for recall — Codman Certas Programmable Valves used for hydrocephalus may not operate properly
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2014
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Codman & Shurtleff, Inc.
Matched: Brand — Incorrect instructions for use (IFU).
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2013
MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Codman & Shurtleff, Inc.
Matched: Brand — Drug flow rates exceeding programmed flow rates.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2013
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Codman & Shurtleff, Inc.
Matched: Brand — Miscalibrated Fill Level Sensor may affect dosing level
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 27, 2013
NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Codman & Shurtleff, Inc.
Matched: Brand — Sterility of device may be compromised due to lack of packaging integrity
23 more products in this recall
FDA (openFDA device enforcement)
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