The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1573-2013·Announced 2013-07-03

Medtronic Sutureless Pump Connector Revision Kit Recalled for Occlusion Risk

Medtronic is recalling Sutureless Pump Connector 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 Sutureless Pump Connector Revision Kit, model 8578. This product is used with Medtronic SynchroMed implantable drug infusion pumps to connect the catheter to the pump. The recall affects 115,722 units distributed worldwide, including the United States and numerous international markets.

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 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.

Consumers and healthcare providers should stop using the recalled products. The source text does not specify specific actions for consumers beyond the recommendation to discontinue use of the previous design.

The recalled product

Product
Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner…
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Implantable Drug Infusion Pump Component
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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