MAUDE reports matching the PowerPort name and implanted vascular port/catheter product code LJT. Recall records match PowerPort product descriptions. Reports include all reported event types and may omit products recorded under different names.
FDA data updates: Oct 13, 2026; Oct 21, 2026. Queries refresh about once a day. Source data may lag reporting by three months or more. These records do not determine whether an individual has a legal claim.
Latest matching enforcement records, up to ten; recall dates are initiation dates. A match does not establish that a particular unit or lot was recalled. Check the product details in the FDA source.
Z-1550-2021 · Class II
Mar 25, 2021 · Status: Terminated
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Reason reported by FDA: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Z-1551-2021 · Class II
Mar 25, 2021 · Status: Terminated
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Reason reported by FDA: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Z-1552-2021 · Class II
Mar 25, 2021 · Status: Terminated
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Reason reported by FDA: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Z-1964-2020 · Class II
Jan 15, 2020 · Status: Ongoing
BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.
Reason reported by FDA: The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Z-1572-2020 · Class II
Oct 1, 2019 · Status: Terminated
1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UDI: (01)00801741027154 2. PowerPort isp M.R.I. Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture Plugs, Ref: 1809661, UDI: (01)00801741027161 3. PowerPort isp M.R.I. Implantable Port with Pre-Attached 9.6F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1859660, UDI: (01)00801741027222 4. PowerPort isp M.R.I. Implantable Port with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter without Suture Plugs, Ref: 1859661, UDI: (01)00801741027239 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Reason reported by FDA: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Z-1570-2020 · Class II
Oct 1, 2019 · Status: Terminated
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, Without Suture Plugs, (01)00801741026737; 3. PowerPort Implantable Port with Pre-Attached 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 1759600 Air Guard, With Suture Plugs, (01)00801741026850 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Reason reported by FDA: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Z-1571-2020 · Class II
Oct 1, 2019 · Status: Terminated
1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741027130 ; 2. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture Plugs, REF: 1809601, UDI: (01)00801741027147; 3. PowerPort M.R.I. Implantable Port With Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1859600, UDI: (01)00801741027208 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Reason reported by FDA: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Z-0582-2020 · Class II
Feb 14, 2019 · Status: Ongoing
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Reason reported by FDA: Complaints received that products packaged with the incorrect introducer sheath size.
Z-2080-2019 · Class II
Jun 25, 2018 · Status: Completed
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.
Reason reported by FDA: Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.
Z-1766-2018 · Class II
Feb 8, 2018 · Status: Completed
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Reason reported by FDA: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Twenty completed calendar quarters (five years), grouped by date received by FDA. Counts reflect matching reports, including possible follow-up or duplicate reports, and represent neither people nor confirmed injuries. A zero means no matches in the available API data; unavailable data is shown separately.