Medtronic Recalls Sutureless Connector Intrathecal Catheters Due to Occlusion Risk
Medtronic is recalling 115,722 Sutureless Connector Intrathecal Catheters worldwide because the previous design has a greater potential for misalignment and occlusion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device (potential occlusion) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Medtronic Neuromodulation is recalling 115,722 units of the Sutureless Connector (SC) Intrathecal Catheter, model 8731SC. The recall covers products with a Use By Date prior to August 25, 2014. These catheters are part of an implantable infusion system used to deliver parenteral drugs to the intrathecal space.
The recall is being conducted because the Sutureless Connector has been redesigned to reduce the potential for occlusion at the catheter-to-pump interface. Medtronic recommends that the previous design no longer be used due to a greater potential for misalignment and subsequent occlusion. The company is removing unused products from the market that were manufactured with the previous design.
The affected products were distributed worldwide, including in the United States and numerous international markets. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors. Contents of inner package
- Manufacturer
- Medtronic Neuromodulation
- 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.
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