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.
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 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…
- Manufacturer
- Bard Peripheral Vascular Inc
- 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
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.
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