The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1576-2013·Announced 2013-07-03

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.

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 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
Category
Medical Device — Implantable Catheter
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 →

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