Bard X-Port isp MRI Implantable Port Recall for Incorrect Tunneler Tip
Bard Peripheral Vascular Inc is recalling 225 X-Port isp MRI Implantable Ports because they may contain a tunneler with an incorrect 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, but the stated hazard is a prolongation of operation rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 225 units of X-Port isp M.R.I Implantable Ports, specifically the models with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter (REF: 0607550, Lot: RECR1508) and with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter (REF: 0657525, Lot: RECU1597). The firm identified that these products 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 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. These implantable ports are indicated for patient therapies requiring repeated access to the vascular system, such as the infusion of medications, I.V. fluids, parenteral nutrition solutions, and blood products.
The FDA has classified this as a Class II recall. The incorrect barb tip can result in a prolongation of the surgical operation. No specific instructions for consumers are provided in the source text, but healthcare providers and patients should be aware of the potential for extended procedure times due to the component mismatch.
The recalled product
- Product
- 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379…
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 225
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)
- 0657525 Lot #: RECU1597 0607550 Lot #: RECR1508
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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