Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-0537-2018·Announced 2018-02-14

Medtronic Ascenda Intrathecal Catheter Recall for Kinking Risk

Medtronic is recalling specific lots of Ascenda Intrathecal Catheters due to a potential risk of kinking at the proximal end where the catheter connects to the drug infusion pump.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a potential mechanical defect (kinking) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Medtronic Neuromodulation is recalling specific lots of the Medtronic Ascenda(R) Intrathecal Catheter, including models 8780, 8781, and 8784. The recall involves 194 units that were distributed nationwide. These catheters are part of an infusion system that delivers drugs to the intrathecal space, connecting an implantable infusion pump to the intrathecal space.

The recall was initiated because there is a possibility that specific lots of catheters recently distributed may be at risk for an increased potential for kinking at the proximal end. This kinking could occur where the catheter connects to the drug infusion pump. The source text does not report any specific illnesses or injuries associated with this defect.

Patients and healthcare providers should check their device lot numbers against the list provided in the official recall notice. If a device is affected, they should contact Medtronic Neuromodulation for instructions on replacement or repair.

The recalled product

Product: Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that…
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Implantable Infusion System
Hazard: kinking
mechanical-failure
Affected units: 194

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)

(a) Model 8780: N740471001
N740482002
N740507001
N741669001
N741918005
N742124002
N742180002
N742214002
N743749002
N747547001
N740471002
N740482003
N740507002
N741669002
N742077001
N742124004
N742180003
N742214003
N743749004
N747547003

Distribution

Distributed nationwide across the United States.

Same manufacturer · Medtronic Neuromodulation

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