Last week, the FDA announced Abbott’s recall of its Dragonfly OpStar Imaging Catheter on May 26, 2022. Abbott recalled the device because some parts of it may break off and remain in the body. The FDA reported that this defect may cause severe injuries, including ischemia, infections, embolisms, thrombosis, and death.
What is a catheter?
A catheter is a flexible tube that healthcare providers insert into a narrow opening in the body. They are used in various medical procedures, including:
- Fluid drainage: Urinary catheters remove urine from the bladder. Some catheters drain abscesses.
- Fluids or medication administration: Healthcare providers use some catheters to intravenously administer fluids or medications, including anesthesia.
- Breathing: Some catheters help patients receive oxygen and other breathable gases.
- Subcutaneous: Healthcare providers place these catheters under the skin’s surface layer to administer various medications, including insulin.
- Heart treatments: Healthcare providers may use catheters to treat narrowed or clogged blood vessels.
Issues with catheters
There have been many catheter recalls for many manufacturers. Some problems associated with catheters are:
- Broken off tip
- The tip is left in the body, typically inside a blood vessel
- Catheter balloon significantly expands
- Catheter failure during a procedure
- Failing to operate as expected
Abbott Dragonfly OpStar Imaging Catheter
So the Abbott Dragonfly OpStar Imaging Catheter is a medical device used during cardiac procedures, specifically for imaging inside the coronary arteries of the heart. The catheter is inserted through a small incision in the patient’s leg and guided through the blood vessels to the heart. Once in position, the catheter uses ultrasound imaging to create a 3D map of the inside of the arteries, allowing doctors to identify and treat blockages and other issues. The device is designed to improve the accuracy and safety of cardiac procedure
Abbott Dragonfly OpStar Imaging Catheter Recall
On May 26, 2022, the FDA announced that Abbott recalled the Dragonfly OpStar Imaging Catheter. The device manufacturer initiated the recall on April 11, 2022. It affected over 4,800 devices in the United States.
Abbott issued the recall because the marker band furthest from the catheter may loosen and separate during a procedure. The FDA reported that leaving the marker band in the body could result in vascular injuries, including thrombosis, an embolism, a dissection, an infarction, ischemia, infection, and death. It also received incident reports, including one injury.
The US Food and Drug Administration (FDA) has classified the recall as a Class I recall, which is the most serious type of recall and is reserved for situations where there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. Patients who have been treated with the recalled catheters and are experiencing any symptoms should contact their healthcare provider immediately.
Again, this is not the only catheter recall in recent months. Let’s look at the others.
Penumbra’s catheter recall
On January 29, 2021, the FDA announced that Penumbra voluntarily recalled its JET 7 Reperfusion Catheter with Xtra Flex Technology. The medical device manufacturer initiated the recall on December 15, 2020.
Penumbra recalled the device because of the risk of severe injury or unexpected death while performing a thrombectomy on a stroke patient. The FDA received over 200 reports associated with the catheter, including severe injuries, malfunctions, and deaths. It received reports of 14 patient deaths.
The FDA found that vessel damage, cerebral infarction, and hemorrhages were the most commonly reported severe injuries. The reported malfunctions include expansion, ballooning, rupture, complete separation, breakage, and internal support coil exposure near the catheter’s distal tip region.
Applied Medical’s catheter recall
On May 12, 2020, the FDA announced that Applied Medical recalled several catheters, including the Python Embolectomy Catheter, the Bard Embolectomy Catheter, and the OTW Latis Cleaning Catheter.
The medical device manufacturer began the recall on October 24, 2019. It recalled the device because of the risk of a catheter detachment. If this occurs, catheter pieces may remain in the patient’s body. The FDA reports that there were 45 complaints about this device since 2015. It received three medical device reports.
Vascular Solution’s catheter recall
On April 30, 2020, the FDA announced that Vascular Solutions recalled its Langston Dual Lumen Catheter. The recall began on March 16, 2020. Vascular Solutions made this recall because of the risk of the inner catheter separating during its use.
Separation may cause severe health conditions, including blood vessel damage or death. The FDA reported that patients may require additional surgeries to remove the separated inner catheter. It also reported physicians may sustain an infection if the dye from a separated inner catheter sprays them. Vascular Solutions received eight complaints.
Boston Scientific’s catheter recall
On April 7, 2020, the FDA announced that Boston Scientific would recall its IMAGER II 5F Angiographic Catheters. The medical device manufacturer began the recall on February 11, 2020.
It made the recall because of the risk of a catheter tip detachment during a surgery or surgery preparation. The FDA reported that using the device might increase the risk of additional surgeries to remove a separated catheter tip from a blood vessel. It also reported that there was an increased risk of stroke, embolism, or death.
LeMaitre Vascular’s catheter recall
On April 2, 2020, the FDA announced that LeMaitre Vascular would recall its Over the Wire Embolectomy Catheter. The medical device initiated the recall on March 10, 2020.
It recalled its devices because the balloon catheter could fail to deflate during use. If this occurs, the catheter tip or balloon may separate and obstruct blood vessels while the surgeon tries to remove the entire device.
The FDA reported that patients may require additional removal surgeries and suffer thrombosis, blood vessel damage, or death.
Abbott’s February NC Trek Catheter recalls
On February 19, 2020, the FDA announced a Class I recall of Abbott’s NC Trek RX Coronary Dilation and NC Traveler RX Coronary Dilation Catheters.
The medical device manufacturer initiated the recall on January 29, 2020. Abbott recalled these devices because the balloons may not properly deflate. The FDA attributed this issue to significant heat exposure during the manufacturing process.
It reported that these devices may cause air embolisms, thrombosis, prolonged cardiac ischemia, a heart attack, and additional surgeries that may cause severe complications, including death. Abbott received 13 complaints on these catheters, including one death.