Catheters

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Manufacturers 

 

Abbott Vascular
Bard (Becton Dickinson)
Boston Scientific
Cook Medical
Edwards Lifesciences
Medtronic
Merit Medical Systems 
ReFlow Medical (Privately Held)
Spectranetics Corp.
Sterilmed (Johnson & Johnson)
Stryker
Teleflex (Vascular Solutions)
Terumo Medical
Vascular Solutions

 

 

Brands / Product Names 

 

Various

Background

Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. A catheter left inside the body, either temporarily or permanently, may be referred to as an "indwelling catheter" (for example, a peripherally inserted central catheter).
 
A vascular access procedure inserts a flexible, sterile plastic tube called a catheter into a blood vessel to allow blood to be drawn from or medication to be delivered into a patient's bloodstream.
 
Over the past decade, there have been many instances of catheter recalls.  The common reason for recalls has been due to the likelihood of the catheter tips breaking off inside of the body.  There have also been reports of sheaths breaking apart as well as issues with parts of the catheter separating and causing air embolisms.

 

 

Treatment / Use

 
Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. A catheter left inside the body, either temporarily or permanently, may be referred to as an "indwelling catheter" (for example, a peripherally inserted central catheter).
 
A vascular access procedure inserts a flexible, sterile plastic tube called a catheter into a blood vessel to allow blood to be drawn from or medication to be delivered into a patient's bloodstream.
 
There are various types of catheters.  Aside from urinary related, there are two types of devices for venous access:  Peripheral Devices and Central Devices.
 
 
Conventional peripheral intravenous (IV) lines are simple, inexpensive, and can be used for short-term IV therapy. Veins are typically accessed in the patient’s hand or arm, and sometimes in the foot. Intravenous lines must be replaced frequently, as the complication rates of infiltration and phlebitis increase dramatically with increased catheter dwell-time. In order to reduce the possibility of phlebitis, the Centers for Disease Control and Prevention recommends replacing peripheral venous catheters and rotating the site at least every 72 to 96 hours.
Midline catheters are inserted into the antecubital (or other upper arm) vein. They are typically 20 cm long and their tips do not reach the central veins of the thorax. They are used for venous access of between 1 and 4 weeks’ duration but are not advised for administration of vesicant or highly irritating drugs that could harm the peripheral veins (eg, chemotherapy). Midline catheters are safe and effective but their use is declining in favor of peripherally inserted central catheters (PICCs), which have similar insertion costs but added benefits of central tip location and longer potential dwell-times.
 
Central lines terminate in the veins within the thorax. Central lines can be classified as either peripherally inserted or centrally inserted central devices. As central venous access is potentially lifesaving, there are no absolute contraindications to performing the procedure; however, knowing which device is most appropriate for each situation might improve patient outcomes.
 
Peripherally inserted central catheter (PICC) lines are indicated in patients requiring several weeks to 6 months of IV therapy. Common indications for PICC lines include parenteral delivery of nutrition, antibiotics, and analgesics, as well as chemotherapy and repeated blood transfusions.
For central insertion, preferred veins include the internal and external jugular. Although access to the subclavian might be technically easy using bony landmarks in the absence of ultrasound guidance, it is generally not advised to place VADs directly into this vein owing to the relatively high incidence of venous thrombosis and the increased risk of catheter damage or fracture associated with subclavian lines.13,14
 
The 3 main types of centrally inserted catheters are as follows: non-tunneled, skin-tunneled, and implantable ports.
 
Non-tunneled Catheters are primarily used for short-term access in the emergency department, operating room, and intensive care unit. These lines are typically meant for rapid resuscitation or pressure monitoring. The lifespan of the catheter is 5 to 7 days, and can provide up to 5 lumens for separate access. These catheters are associated with a higher risk of infection and are inappropriate for patients who require central venous access for longer than 2 weeks.
 
Skin-tunneled catheters, such as Hickman catheters, are appropriate for longer residence and reduce the incidence of infection by increasing the distance between the skin entry site and the venotomy. Although they provide reliable long-term access, their complications include thrombosis, occlusion, and infection.
These lines are favored in patients requiring frequent and long-term venous access, particularly for infusion of blood products.
 
Implantable ports consist of a catheter attached to a reservoir that is implanted into a surgically created pocket on the chest wall or upper arm. A needle is inserted through the port’s septum to access the reservoir. Advantages include less interference with daily activities, less frequent flushing, and reduced risk of infection. Disadvantages include the need for needle insertion, increased discomfort, and the risk of extravasation. These devices are expensive, and are more difficult and time-consuming to insert and remove.
 
Many of these catheters are used during procedures involving the upper body (i.e. angiograms, angioplasty, heart valve replacement, etc.  However, there have been issues with these products involving MRIs, X-Rays, CT Scans, Biopsies and other medical procedures.

Injuries / Complications / Concerns

 
Due to the problems with the recalled catheters, patients have suffered injuries ranging from internal bleeding, organ damage, blood clots, embolisms, additional surgeries and even death.
 
Many of the recalls are due to breaking or separating of catheters inside the patient’s body causing internal bleeding, embolisms, organ damage, additional surgeries to remove the broken device, and death.
 
There have been more than 5 million catheter or catheter related recalled products since 2013.  Cook Medical has been the manufacturer for many of the recalled products.

Information on the Topic of Catheter

 

Medtronic Catheter is Recalled After One Death, Two Injuries (11-4-2020)

https://www.startribune.com/medtronic-catheter-is-recalled-after-one-death-two-injuries/572974762/?refresh=true

 

Recall Notifications – Becton Dickinson (11-4-2020)

https://www.bd.com/en-us/support/recall-notifications

 

Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues

(11-3-2020)

https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-rashkind-balloon-septostomy-catheters-quality-issues

 

Flared-End, Thoracic Catheter Recall (8-27-2020)

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73893r-eng.php

 

FDA Flags 2nd High-Risk Recall of Embolectomy Catheters in Recent Weeks

(5-13-2020)

https://www.medtechdive.com/news/fda-flags-2nd-high-risk-recall-of-embolectomy-catheters-in-recent-weeks/577846/

FDA Designates Recall of Three Latex Balloon Catheters as Class 1 (5-13-2020)

https://www.healio.com/news/cardiac-vascular-intervention/20200513/fda-designates-recall-of-three-latex-balloon-catheters-as-class-1

 

Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During Use (Class 1) (5-12-2020)

https://www.fda.gov/medical-devices/medical-device-recalls/applied-medical-recalls-python-embolectomy-bard-embolectomy-and-otw-latis-cleaning-catheters-due

 

Vascular Solutions Recalls Dual Lumen Catheters After Numerous Complaints

(5-5-2020)

https://www.cardiovascularbusiness.com/topics/vascular-endovascular/vascular-solutions-recall-dual-lumen-catheter

 

These Catheters Used in Heart Surgery have Caused 9 Injuries.  They’ve Been Recalled (4-8-2020)

https://www.miamiherald.com/news/health-care/article241836811.html

FDA Class I Recall for Boston Scientific’s IMAGER II Angiographic Catheters

(4-7-2020)

https://www.tctmd.com/news/fda-class-i-recall-boston-scientifics-imager-ii-angiographic-catheters

 

LeMaitre Vascular Recalls Catheter Over Defect (4-3-2020)

https://www.spglobal.com/marketintelligence/en/news-insights/latest-news-headlines/lemaitre-vascular-recalls-catheter-over-defect-57897942

 

Abbott Recalls Two Coronary Balloon Catheters that May Not Deflate (2-24-2020)

https://www.dicardiology.com/content/abbott-recalls-two-coronary-balloon-catheters-may-not-deflate

 

Medtronic Recalls More than 100k Guide Catheters for Fragment Risk (10-9-2019)

https://www.medtechdive.com/news/medtronic-recalls-more-than-100k-guide-catheters-for-fragment-risk/564627/

Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue (10-8-2019)

https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-6-french-sherpa-nx-active-guide-catheters-due-separation-and-fragmentation-issue

 

Edwards Lifesciences, LLC, Recalls SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery, Which May Result in Vascular Injury, Bleeding, or Surgical Intervention (7-8-2019)

https://www.fda.gov/medical-devices/medical-device-recalls/edwards-lifesciences-llc-recalls-sapien-3-ultra-delivery-system-due-burst-balloons-during-surgery

 

Edwards Lifesciences Recalls the IntraClude Intra-Aortic Occlusion Device Due to Risk of Balloon Rupture (5-14-2019)

https://www.fda.gov/medical-devices/medical-device-recalls/edwards-lifesciences-recalls-intraclude-intra-aortic-occlusion-device-due-risk-balloon-rupture

 

Terumo Medical Corporation Recalls SOLOPATH® Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System Due to Dislodgement of the Fairing Tip from the Sheath (4-26-2019)

https://www.fda.gov/medical-devices/medical-device-recalls/terumo-medical-corporation-recalls-solopathr-balloon-expandable-transfemoral-system-and-re