The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1574-2013·Announced 2013-07-03

Medtronic Recalls Intrathecal Catheter Pump Segment Revision Kits

Medtronic is recalling unused Model 8596SC Pump Segment Revision Kits due to a design flaw that increases the risk of catheter occlusion.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with…"

Plain-English summary

Medtronic Neuromodulation is recalling the Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. The recall involves 115,722 units distributed worldwide, including the United States and numerous international markets. The affected products are those with a Use By Date prior to August 25, 2014.

The recall is being conducted because the Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing unused products manufactured with the previous design from the market. The company recommends that the previous design no longer be used due to a greater potential for misalignment and subsequent occlusion.

The Model 8596SC Pump Segment Revision Kit is used when a revision to the pump segment of the Model 8731 or Model 8731SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731 or Model 8731SC catheter, which connects to the pump at the catheter port. The contents of the inner package are sterile.

The recalled product

Product
Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strain-relief sleeves, Connector pin. Contents of inner package are STERILE. The…
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Implantable Infusion System
Hazard
Affected units
115,722

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product having a Use By Date prior to 25 Aug 2014

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Medtronic Neuromodulation

See all →

Same hazard · occlusion

See all →

Similar recalls