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Abbott Initiates Voluntarily Recall of Specific Lots of Three Coronary Catheters

COMPANY ANNOUNCEMENT

This recall has been completed and FDA has terminated this recall.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Company Announcement

Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter.

This recall does not affect patients who have successfully undergone cardiac procedures using these devices. Abbott has already implemented corrective actions to ensure the products perform as intended.

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. In one reported case, failure to deflate the balloon necessitated surgery, which resulted in multiple post-surgical complications leading to death. The FDA has classified this as a Class I recall, where exposure to a device presents a reasonable likelihood of serious adverse health consequences or death. The cumulative frequency of reported events in difficulty of removing the sheath, and inflation and deflation of the balloon, is 0.12 percent worldwide.

Abbott began contacting customers in March who received coronary catheters from the affected lots, and is arranging the return and replacement of all remaining products. The total number of distributed units from identified lots potentially affected is 449,661. Global Health Authorities have been notified of the voluntary recall.

Specific lots of affected product were manufactured between Jan. 1, 2015 – Jan. 2, 2017, and were distributed between Jan. 13, 2015 – March 14, 2017. For more information, please see Abbott’s field safety notice .

For Important Safety Information on NC Trek Catheters visit Abbott's home page .

Consumers with questions may contact the company via telephone at (800) 227-9902 between the hours of 5 a.m. and 5 p.m. PST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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FDA Update | Recall of Abbott NC Trek RX and NC Traveler RX Coronary Dilatation Catheters

Cardiology Magazine

Abbott Vascular is recalling the NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheter, due to reports that the balloons from the impacted lots "may not deflate as intended" because of weaker material close to the balloon bond, resulting from excessive exposure to heat during manufacturing.

This recall impacts balloon diameters 4.0 mm, 4.5 mm and 5.0 mm.

The U.S. Food and Drug Administration has stated that use of these devices may cause "serious adverse health consequences, such as prolonged cardiac ischemia, air embolism, thrombosis, myocardial infarction and additional surgery that could lead to post-operative complications, including death."

Abbott Vascular has received 13 complaints related to this issue, with one death being reported.

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Abbott NC Trek Coronary Dilatation Catheters - NC Trek Catheter, Rapid, 3.5 mm x 20 mm - 1012451-20

Questions? Speak with a specialist!

This item may require 5-7 days to ship out from our facility.

Product Information: NC Trek Catheter, Rapid, 3.5 mm x 20 mm

Manufacturer Part # 1012451-20

Description

• Coronary dilatation catheter with multilayer CrossFlex balloon helps provide flexibility and trackability for crossing stents and lesions
• Flexible dual tungsten markers help enable smooth, precise tracking while providing controlled and confident placement
• Smooth, rounded tip designed for ease of maneuverability through calcified lesions and stent struts
• Short, steep tapers for focused dilatation on lesion and not surrounding healthy tissue
• Limited longitudinal growth helps predict dilatation within treatment area

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Fda: abbott recalls nc trek rx and nc traveler coronary catheters, some of the dilatation catheters are not deflating properly. one patient has died from postprocedural complications..

• Created with Sketch.

Abbott has voluntarily recalled specific lots of two coronary angioplasty catheters—the NC Trek RX coronary dilatation catheter and the NC Traveler coronary dilatation catheter—in three balloon diameters: 4.0, 4.5, and 5.0 mm.

The US Food and Drug Administration has classified the action as a Class I recall, its most serious category.

Affected products may deflate slowly, partially, or not at all, potentially causing “prolonged cardiac ischemia, air embolism, thrombosis, myocardial infarction, and additional intervention, such as surgery that could lead to postoperative complications which include death,” FDA’s MedWatch alert stated.

According to the manufacturer, the frequency of reported events is 0.12% worldwide, and at the time the field notice was issued, there had been no patient deaths. Since then, said the FDA, “Abbott has become aware of one reported case in which the inability to deflate the balloon necessitated intervention, which resulted in postprocedural complications leading to a patient death.”

The FDA action follows a Field Safety Notice , issued by Abbott on January 29, making hospitals and physicians aware of the affected lots—estimated at 40,429—that were distributed between August 16, 2019, and January 3, 2020. Any hospitals that have the defective products in stock are asked to stop using them immediately and return any that are unused to the company.

Providers are urged to read the field notice and report any problems to the manufacturer. 

Shelley Wood is Managing Editor of TCTMD and the Editorial Director at CRF. She did her undergraduate degree at McGill…

• Disclosures

US Food and Drug Administration. Abbott initiates voluntary recall of specific lots of two coronary catheters . Published on: February 20, 2020. Accessed on: February 24, 2020.

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DEVICE: NC TREK NEO™ (08717648232831)

Device identifier (di) information, device characteristics.

GMDN© Term Code, Names and Definitions ( * Terms of Use ): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

FDA Product Code

Fda premarket submission, sterilization, storage and handling, clinically relevant size, device record status, alternative and additional identifiers additional identifiers, secondary di, unit of use di, direct marking (dm), production identifier(s) in udi, customer contact, device record history (6775e526-e175-407a-8dd1-bc8587841733).

NC Trek RX and NC Traveler Coronary Dilatation Catheters by Abbott

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Recall of NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter by Abbott due to possible balloon malfunction.

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NC TREK NEO™ Coronary Dilatation Catheter 3.25 mm x 12 mm / Rapid-Exchange

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NC TREK NEO™ Coronary Dilatation Catheter 3.25 mm x 12 mm / Rapid NC TREK NEO™ - 1400325-12

A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.

• Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C to -20 °C), storage is recommended in a dry, dark, cool place.
• Balloon Diameter: 3.2500 Millimeter
• Balloon Length: 12.0000 Millimeter

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Device Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous

Device Class: 2

Physical State: N/A

Definition: A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.5100

Third Party Flag: N

Medical Specialty: CV

Device Id: 08717648232572

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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CARDIOVASCULAR

Trek™ & mini trek™ coronary dilatation catheters.

Designed with Smooth Transitions for Challenging Anatomy

TREK™  Coronary Dilatation Catheter’s unique design provides smooth transitions from hub to tip.

• Transitionless tip
• Flexible distal shaft
• Multi-layer CrossFlex²* balloon and Slim Seal** technology  

Mini Trek™ Coronary Dilatation Catheter Indicated for Treatment of De Novo Chronic Total Occlusions

MINI TREK™  Coronary Dilatation Catheter’s ultra low profile design enables lesion access.

• Small chassis designed distinctively for MINI TREK™ Coronary Dilatation Catheter
• Available in sizes as small as 1.20 mm

Hypotube Design

Skive design provides smooth transition between hypotube and distal shaft.

Transitionless Tip

Confident crossing in resistant lesions.

Slim Seal ** Technology

Provides reduced wall thickness for flexibility and low tip crossing profiles.

Flexible Tungsten Markers †

Radiopaque flexible markers for confident placement.

Multi-layer Crossflex²* Balloon

Thin, multi-layer balloon technology provides low crossing profiles for access to complex lesions and a tri-fold design ††  for excellent re-wrap.

Technical Information

Ordering Information

Broad size matrix with 77 rx sizes and 75 otw sizes.

Compliance Chart

Data on file at Abbott. **Slim Seal technology available on 2.0 mm – 3.75 mm balloon sizes. † Single marker on all 6 mm lengths and 1.20 – 1.50 mm diameters (all lengths). Dual markers on all other sizes. *CrossFlex 2  technology available on 2.25 mm – 5.0 mm balloon sizes. †† Tri-fold design for 2.00 mm – 4.00 mm diameters. Bi-fold design for 1.20 mm & 1.50 mm diameters.

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Information contained herein for distribution outside the U.S. only. CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. © 2024 Abbott. All Rights Reserved. MAT-2001111 v7.0

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Abbott 1400300-15 NC TREK NEO™ Coronary Dilatation Catheter, 3.00 mm X 15 mm, 145 cm. Box of 01

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Product Description

Abbott 1400300-15 NC TREK NEO™ Coronary Dilatation Catheter, 3.00 mm X 15 mm, 145 cm. Box of 01

NC TREK NEO™ Balloon is the newest generation non-compliant balloon re-engineered for challenging anatomy

NC TREK NEO™ Balloon delivers a broad size matrix, excellent pushability and exceptional balloon performance for challenging anatomy.

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