The Recall Desk
ModerateFDA (Devices)·Z-1575-2020·Announced 2020-04-01

BardPort Titanium Implantable Port Recall Due to Incorrect Catheter Tip

Bard Peripheral Vascular Inc is recalling 360 BardPort Titanium Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgery.

What this means for you

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 stated hazard is a procedural delay (prolongation of operation) rather than a direct physical injury or death, fitting the Moderate severity criteria for low-risk issues.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 360 units of the BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter (REF: 0602230, Lot # RECR2059). The recall was initiated because the firm identified that the product may incorrectly contain a tunneler with a barb tip designed for a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter.

The affected devices were distributed worldwide, including nationwide in the United States and in specific countries such as Brazil, Canada, EMEA, Korea, Mexico, and New Zealand. The use of the incorrect barb tip can result in a prolongation of the surgical operation.

Healthcare providers and patients should contact Bard Peripheral Vascular Inc for further instructions regarding the return or replacement of these devices.

The recalled product

Product
BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system ca
Affected units
360

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 # RECR2059

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 →