FDA Announces Recall of Several Models of Medtronic Catheters and Revision Kits
On September 24, 2009, the U.S. Food and Drug Administration (FDA) announced it had notified healthcare professionals of a Class 1 recall of certain Medtronic SC Catheters and Revision Kits. The FDA issues Class 1 recalls in cases where the use of a drug or medical device can patients at risk for serious adverse health effects or death.
Recall Class:
Class I
Date Recall Initiated:
August 27, 2009
Product:
INDURA 1P Intrathecal Catheter, model 8709SC
Intrathecal Catheter, model 8731SC,
Sutureless Pump Connector Revision Kit, model 8578
Intrathecal Catheter Pump Segment Revision Kit, model 8596SC
These devices were distributed beginning on January 1, 2007 and are still in distribution.
Use:
The intrathecal catheter and intrathecal catheter revision kits use a sutureless connector for the final connection to the implanted Medtronic SyncroMed II and SynchroMed EL infusion pumps. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal and vascular spaces.
The catheters with sutureless connectors CANNOT be used with the IsoMed infusion pumps.
Recalling Firm:
Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568
Reason for Recall:
The current labeling for Medtronic Sutureless Connector (SC) catheters and revision kits (known collectively as SC catheters) incorrectly states that SC catheters are intended to be used with Medtronic IsoMed constant-flow infusion pumps. SC catheters can only be used with Medtronic SynchroMed II and SynchroMed EL pumps. SC catheters cannot be used with Medtronic IsoMed pumps. A physical interference between the SC catheter connector and the IsoMed pump prevents the SC catheter from completely connecting to the IsoMed pump even though it may appear to be connected and feels secure. Once an SC catheter is connected to an IsoMed pump, the sutureless connector is considered damaged. This incompatibility is a design issue and is not related to the implant technique. An incomplete connection may result in a catheter disconnection from the IsoMed pump or a blockage may occur at the connection site. Connecting an SC catheter to an IsoMed pump does not damage the IsoMed pump.
Public Contact:
Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 AM to 5 PM Central Time.
Physicians with questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday – Friday, 8 AM to 5 PM Central Time.
FDA District:
Minneapolis
FDA Comments:
During August, 2009, the company sent a letter to implanting and managing physicians concerning the:
nature of the issue
range of the affected products
potential severity of the issue
recommendations
A copy of this letter was also sent to the risk manager at each hospital associated with SC catheter physicians. The company asked each healthcare professional to complete and return the reply card that was enclosed with the letter.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
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