PowerPort ClearVUE recallZ-1761-2018 · Bard Peripheral Vascular Inc · initiated Feb 8, 2018
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bard Peripheral Vascular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
FDA root cause category: Error in labeling
What the company is doing
The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
Recall details
- Recall number
- Z-1761-2018
- Status
- Completed
- Initiated by the company
- Feb 8, 2018
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 2395 units
- Product code
- LJT
- FDA submissions
- K063377
- Distribution
- Nationwide
Product description
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
Code information (models, lots, serial numbers)
Lot Number Unique Device Identifier (UDI) REAN0058 (01)00801741110740(17)170628(10)REAN0058 REAN0205 (01)00801741110740(17)170628(10)REAN0205 REAN1124 (01)00801741110740(17)170628(10)REAN1124 REAP0769 (01)00801741110740(17)170728(10)REAP0769 REAT1312 (01)00801741110740(17)171128(10)REAT1312 REBP1357 (01)00801741110740(17)180131(10)REBP1357 REBR0999 (01)00801741110740(17)180731(10)REBR0999 REBV0758 (01)00801741110740(17)180930(10)REBV0758
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PowerPort ClearVUE 1668362Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall1 death37 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 79841).
- Z-1760-2018 · CompletedPOWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
- Z-1762-2018 · CompletedPOWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
- Z-1763-2018 · CompletedPOWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
- Z-1764-2018 · CompletedPOWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
- Z-1765-2018 · CompletedPOWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
- Z-1766-2018 · CompletedPOWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
- Z-1767-2018 · CompletedPOWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
- Z-1768-2018 · CompletedPOWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
- Z-1769-2018 · CompletedPOWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
- Z-1770-2018 · CompletedPOWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
- Z-1771-2018 · CompletedPOWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
- Z-1772-2018 · CompletedPOWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
- Z-1773-2018 · CompletedPOWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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