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.
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 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…
- 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.
See all 10 products in this recall →Related recalls
Same manufacturer · Bard Peripheral Vascular Inc
See all →- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- HighCatheter cutdown trays recalled over damage to the outer tray
FDA (Devices) · 2026-02-25
- HighDrainage catheter trays recalled over safety indicators showing the wrong position
FDA (Devices) · 2025-12-17
- ModerateVein ablation generators recalled over software falsely flagging working catheters
FDA (Devices) · 2025-10-08
- CriticalRotarex Atherectomy Catheter Recalled for Helix Fracture Risk
FDA (Devices) · 2025-03-12
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateBard PowerPort isp M.R.I. Implantable Port Recalled for Incorrect Sheath Size
FDA (Devices) · 2019-12-04
- ModerateBard PowerPort ClearVUE Slim Implantable Port Recalled for Incorrect Catheter Lock Size
FDA (Devices) · 2020-05-20
- ModerateBard POWERPORT ClearVUE Implantable Port Recall for Incorrect Instructions
FDA (Devices) · 2018-05-16
- HighBard PowerPort duo M.R.I. Implantable Port Recall for Catheter Issues
FDA (Devices) · 2021-05-19
- HighBard PowerPort duo MRI Implantable Port Recalled for Catheter Function Issues
FDA (Devices) · 2021-05-19
- ModerateBard POWERPORT ClearVUE Implantable Port Recalled for Incorrect Flushing Instructions
FDA (Devices) · 2018-05-16