Z-2080-2019Class II

POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F...

Name: Z-2080-2019 POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F...
Creator: Bard Peripheral Vascular Inc
Published: 2018-06-25
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2018-06-25 / Completed / root cause: design

FDA source

Bard Peripheral Vascular Inc began a recall of POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA... on 2018-06-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-2080-2019
Classification: Class II
Status: Completed
Initiated: 2018-06-25
Posted: 2019-07-25
Recalling firm: Bard Peripheral Vascular Inc
Product: 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.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: On June 25, 2018 Bard sent recall notifications to all their customers informing them of the following: "This letter is to inform you of a voluntary product recall issued by Bard Peripheral Vascular, Inc. (BPV), a wholly owned subsidiary of Becton, Dickinson and Company. Specific product code / lot number combinations of the NAUTILUS DELTA" Port Kits are affected as outlined in Attachment 3. These product code / lot number combinations cannot be used with the NAUTILUS DELTA" Tip Confirmation System (TCS), product code 9770323. All other product code / lot number combinations not listed in Attachment 3 can continue to be used by your facility as they are safe to use and are not affected by this product recall. Reason for Recall: Per the current Instructions for Use (IFU), the NAUTILUS DELTA" TCS can be used with implantable ports; however, BPV has identified that the NAUTILUS DELTA" Port Kit product code / lot number combinations listed in Attachment 3 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. During port placement procedures, once the guidewire and dilator have been removed and the catheter is inserted into the introducer sheath, the catheter is flushed with saline through the port flushing hub with attached NAUTILUS DELTA" E Electrical Adaptor (provided with the NAUTILUS DELTA" Port Kits). This should cause an intravascular ECG waveform to appear; however, in multiple instances, it has been reported that no intravascular waveform is generated or the intravascular waveform is generated and subsequently lost. Clinical Risk Statement: The loss of or lack of intravascular signal while advancing the port catheter eliminates the devices intended use, which is to provide catheter tip navigation and positioning guidance based on specified ECG signals. This lack of consistent intravascular signal may lead to a prolonged procedure or inabi
Quantity in commerce: 95 units
Distribution: US Nationwide Distribution in the states of FL, CO, WI, OH, IL, KS, AZ, WV, CT, PA, AL, MI and VA
Product codes and lots: REBR1147, REBR1148, REBR1149, REBT0471, RECQ2162 and REBR1150

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2080-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2080-2019	Class II	Completed	Voluntary: Firm initiated	2019-07-31	2019-07-25

Product code LJT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)