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U.S. Department of Health and Human Services

Class 2 Device Recall Powerport Cleavue Slim Implantable Port

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  Class 2 Device Recall Powerport Cleavue Slim Implantable Port see related information
Date Initiated by Firm June 25, 2018
Create Date July 25, 2019
Recall Status1 Completed
Recall Number Z-2080-2019
Recall Event ID 82513
510(K)Number K122899  K063377  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
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.
Code Information REBR1147, REBR1148, REBR1149, REBT0471, RECQ2162 and REBR1150
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
For Additional Information Contact Garth Conrad
480-303-2602
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LJT and Original Applicant = C.R. BARD, INC.
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