Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2768-2017·Announced 2017-08-02

Medtronic Recalls DLP Pressure Display Sets Due to Packaging Pinholes

Medtronic Perfusion Systems is recalling DLP Pressure Disposable Pressure Display Sets because small pinholes were found in the sterile packaging.

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 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 II, and the hazard involves a packaging defect (pinholes) that compromises sterility. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Medtronic Perfusion Systems is recalling DLP Pressure Disposable Pressure Display Sets, which are used to extend pressure lines during cardiopulmonary bypass surgery. The recall was initiated after small pinholes were identified in a single packaging configuration of the sterile pouches.

The recall affects a total of seven different products, including Model No. 61000 and Model 62000. The affected units were distributed worldwide, including in the United States and numerous foreign countries such as Argentina, Australia, Canada, France, Germany, Japan, and the United Kingdom.

Healthcare providers and consumers should stop using the affected DLP Pressure Disposable Pressure Display Sets and contact Medtronic Perfusion Systems for further instructions or a replacement.

The recalled product

Product: DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Manufacturer: Medtronic Perfusion Systems
Category: Medical Device — Surgical Equipment
Hazard: packaging-defect
sterility-compromise

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)

Model No. 61000: Product UPN: 20613994846604: Lot No. 2016020865
2016030859
2016031538
2016040539
2016040859
2016050268
2016050556
2016051179
201605C063
201605C064
201605C065
201605C066
201605C067
201605C068
201605C069
2016060275
2016060525
2016060896
2016060897
2016061082

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Medtronic Perfusion Systems 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 5 products in this recall →

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · packaging defect