Agency classClass IIOur severity:High FDA (Devices)·Z-1568-2014·Announced 2014-05-14

Medtronic Refill Kits Recalled Due to Occluded Extension Tubing Sets

Medtronic is recalling specific Refill Kits for implantable infusion pumps because some contain occluded extension tubing that prevents filling. No patient injuries beyond additional needle sticks have been reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 product (occluded tubing preventing pump filling) where injury has not yet been reported beyond additional needle sticks, fitting the High severity criteria for theoretical or minor reported harm without serious injury.

Plain-English summary

Medtronic Neuromodulation is recalling 13,784 units of Refill Kit 8551/856X (including Models 8561, 8562, and 8564) intended for use with Medtronic Implantable Programmable Infusion Pumps. The recall affects specific lots distributed between January 2014 and March 2014. The affected lots were distributed worldwide, including in the United States (specifically New Mexico, North Dakota, Rhode Island, and Vermont) and in countries across Australia, Singapore, Thailand, Central and Eastern Europe, Western Europe, the Middle East, and Panama.

The recall was initiated because some refill kits in the affected lots may contain an extension tubing set that is occluded. This defect may prevent healthcare professionals from aspirating or filling SynchroMed pumps. The source text explicitly states that there is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits.

Healthcare professionals and patients should be aware that this issue may result in additional needle sticks during attempts to refill the pump. The source text notes that there have been no patient injuries beyond these additional needle sticks associated with this issue.

The recalled product

Product: Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic…
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Implantable Infusion Pump Accessories
Hazard: device-malfunction
inability-to-administer-medication
Affected units: 13,784

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 (20)

Lot numbers CS3643
CS3613
CS3663
N441998
N442081
N442131
N440259
N440527
N440582
N440654
N440909
N440978
N441199
N441268
N441806
N441817
N442178
N442513
N442532
N442560

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Same manufacturer · Medtronic Neuromodulation

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