Agency classClass IIOur severity:High FDA (Devices)·Z-2504-2021·Announced 2021-09-29

DLP Left Heart Vent Catheters recalled due to potential wire protrusion

Medtronic is recalling 51,494 DLP Left Heart Vent Catheters due to potential wire protrusion through the catheter tip. This defect could compromise proper device function during use.

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: This is an FDA Class II recall. The defect is described as 'potential wire protrusion,' indicating a theoretical hazard without reported injuries or illnesses. The catheter is used in surgical procedures and wire protrusion could compromise device function.

Plain-English summary

Medtronic Perfusion Systems is recalling DLP Left Heart Vent Catheters, 16 FR (Model/Reference Number 12116). The recall involves approximately 51,494 units with expiration dates ranging from September 30, 2020, to May 19, 2024. The catheters were distributed nationwide across the United States and internationally.

The catheters have a potential for wire protrusion through the left heart vent catheter tip. This defect could affect proper device function.

Affected lot numbers have been identified by Medtronic and reported to the FDA. Healthcare providers and facilities should verify their inventory against the affected lot numbers.

The recalled product

Product: DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Manufacturer: Medtronic Perfusion Systems
Category: Medical Device — Surgical / Cardiac
Hazard: wire-protrusion
device-malfunction
Affected units: 51,494

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/Reference Number 12116
Lot Number (GTIN Number): 2018080039 (20643169086719)
2018091020 (20643169086719)
2018100911 (20643169086719)
2018111023 (20643169086719)
2018111419 (20643169086719)
2019120925 (20643169086719)
2018080039 (00673978462943)
2018091020 (00673978462943)
2018100911 (00673978462943)
2018111023 (00673978462943)
2018111419 (00673978462943)
2018120581 (20643169086719)
2018120581 (00673978462943)
2018120582 (20643169086719)
2018120582 (00673978462943)
2018121084 (20643169086719)
2018121084 (00673978462943)
2019010456 (20643169086719)
2019010456 (00673978462943)

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · wire protrusion