Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1577-2020·Announced 2020-04-01

BardPort M.R.I. Hard Base Implantable Port Recall Due to Incorrect Tunneler Tip

Bard Peripheral Vascular Inc is recalling 151 BardPort M.R.I. Hard Base Implantable Ports because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.

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. The identified hazard is a manufacturing error that may prolong surgical operations, which is a procedural inconvenience rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity recall.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 151 units of the BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter (Ref: 0604550, UDI: (01)00801741025860). The recall involves Lot # RECR1431. The product is indicated for patient therapies requiring repeated access to the vascular system, including the infusion of medications, I.V. fluids, parenteral nutrition solutions, and blood products.

The firm identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This manufacturing error can result in a prolongation of the surgical operation.

The affected products were distributed worldwide, including nationwide distribution in the United States across numerous states and territories, as well as in Brazil, Canada, EMEA, Korea, Mexico, and New Zealand. Healthcare providers and patients should contact Bard Peripheral Vascular Inc for further instructions regarding the recall and replacement of the affected devices.

The recalled product

Product: BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)00801741025860 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port…
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Implantable Port
Hazard: manufacturing-error
procedural-delay
Affected units: 151

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)

Lot # RECR1431

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 10 recalled by Bard Peripheral Vascular Inc 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 10 products in this recall →

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