Bard PowerPort Implantable Ports Recalled Due to Incorrect Catheter Barb Tip
Bard Peripheral Vascular Inc is recalling 178 PowerPort implantable ports because they may contain a tunneler with an incorrect barb 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. The stated hazard is a prolongation of the operation due to a component mismatch, which is a procedural inconvenience 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 178 units of PowerPort Implantable Ports with attachable or pre-attached 9.6 Fr open-ended single-lumen venous catheters. The recall involves specific reference numbers 1709600, 1709601, and 1759600, with lot numbers RECT0088, RECU1601, and RECS1276 respectively.
The firm identified that the products may incorrectly contain a tunneler with a barb tip designed for a 6 Fr catheter instead of the correct barb tip for a 9.6 Fr catheter. This manufacturing error can result in a prolongation of the surgical operation. The affected products were distributed worldwide, including nationwide in the United States and in countries such as Brazil, Canada, EMEA, Korea, Mexico, and New Zealand.
These devices are 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. Healthcare providers and patients should contact Bard Peripheral Vascular Inc for further instructions regarding the recall.
The recalled product
- Product
- 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single- Lumen Venous Catheter, REF: 1709601, Air Guard, Wit
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 178
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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