Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1576-2020·Announced 2020-04-01

BardPort M.R.I. Implantable Port Recall Due to Incorrect Catheter Tip

Bard Peripheral Vascular Inc is recalling BardPort M.R.I. Implantable Ports because they may contain an incorrect catheter 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, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Bard Peripheral Vascular Inc is recalling BardPort M.R.I. Implantable Ports with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheters (REF: 0602680). The recall involves 2,493 catheters from lots RECU2404, RECU1067, RECR1439, and RECT0078. The products were distributed worldwide, including nationwide in the United States and in Brazil, Canada, EMEA, Korea, Mexico, and New Zealand.

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 error can result in a prolongation of the surgical operation.

Healthcare providers and patients should contact Bard Peripheral Vascular Inc for further information regarding the recall and potential replacement or repair of the affected devices.

The recalled product

Product: BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be…
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Implantable Port
Hazard: manufacturing-error
surgical-delay
Affected units: 2,493

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 (4)

Lot # RECU2404
RECU1067
RECR1439
RECT0078

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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