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Model 8709SC Indura 1P recallZ-2173-2008 · Medtronic Neuromodulation · initiated Apr 14, 2008

Terminated All recalls posted in August 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.

FDA root cause category: Device Design

What the company is doing

Medtronic informed all Belgium implanting and managing physicians of the SynchroMed II infusion system. Each customer was mailed a Dear Healthcare Professional letter (Medtronic Urgent: Field Safety Notice) on 4/3/08 providing important safety information and patient management recommendations regarding the device incompatibility. The firm recommends that healthcare professionals do not use SC catheters if a connection with an implantable access port is required. Also, if a continuous infusion trial is required with use of an implantable access port, they should use a model 8711 intrathecal catheter. The firm states that for patients who are currently undergoing a continuous trial with an implantable port, replacing the catheter connector before connecting to the SynchroMedd II using the Medtronic model 8578 revision kit is recommended. Medtronic also recommends discussing the risks of connection failure with patients. Local field reps will personally follow-up with affected customers to confirm and document notification.

Recall details

Recall number
Z-2173-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 14, 2008
Posted by the FDA
Aug 27, 2008
Recalling firm
Medtronic Neuromodulation
Quantity
232 total from all models
Product code
LKK
FDA submissions
P860004
Distribution
International Distribution --- country of Belgium.

Product description

Model 8709SC Indura 1P One-Piece Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.

Code information (models, lots, serial numbers)

All lots numbers included

Other devices under the same FDA submission

51 devices cleared under P860004 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 48616).

Sources and updates

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