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The FDA has issued a Class I recall for intra-aortic balloon pumps manufactured by the Maquet Datascope Corporation over more than eight years from early 2003 through mid 2011.
Intra-Aortic Balloon Pump Description and Operation
Intra-aortic balloon pumps generally are used to augment cardiovascular operation, particularly during life-threatening situations. Specifically, IABPs are indicated as a mechanism to increase blood flow into the heart as well as throughout the patient’s whole body.
According to the FDA’s description, the device consists of the following parts:
- Inflatable balloon positioned in the thoracic aorta.
- Control system to oversee and automate the balloon operation in conjunction with the cardiac system.
The device works by repeatedly inflating and deflating, aiding or even taking over the heart’s own functionality. The device is often used temporarily in emergency circumstances, such as after a heart attack, during severe cardiac events, or in preparation for heart surgery, to help ensure an adequate supply of blood to the heart and the rest of the body.
The FDA explicitly disallows the use of intra-aortic balloon pumps in the following situations: 1
- Severe aortic insufficiency – A serious condition in which blood flows the wrong way through the aortic valve
- Aortic aneurysm – Extreme enlargement of the aorta, which can cause general weakness of this major artery
- Aortic dissection – Rupture of the aorta wall that causes the blood vessel’s layers to separate
- Severe peripheral vascular disease – Obstruction of large arteries, especially the aortoiliac and femoral arteries
- Severe coagulopathy – Impairment of the blood’s clotting capability
- Sepsis – Inflammation spread throughout the entire body produced by extreme infection
Maquet Intra-Aortic Balloon Pump Models
As of September 2014, Maquet Datascope Corporation has four IABP models on the market.
- Cardiosave® IABP Hybrid & Rescue: Claimed by the company to be smaller and lighter than any other model that Maquet has produced, this device is marketed for use as a transportable IABP that can be lifted easily into vehicles.
- Sensation® 7Fr. & CS300™ IABP System: This model is made with fiber-optic connections and a small IAB catheter, which the company alleges can help minimize vascular complications.
- CS300™ IABP with Intellisense: Maquet advertises this model as being fast and convenient, with automatic calibrations and adjustments purported to reduce the need for clinical monitoring.
- CS100® IABP with IntelliSync™: According to Maquet marketing materials, this device uses timing algorithms to adjust the pump in case the heart’s rhythm changes.
Risks Related to Intra-Aortic Balloon Pumps
Many different risk factors and complications can arise from intra-aortic balloon pumps.
|Access site bleeding||Various studies have shown that as many as a quarter of patients may encounter bleeding at the IABP’s access site. However, incidence was found to be much lower in some studies than others.|
|Ruptured aorta||A ruptured aorta is a serious, and possibly fatal, complication that has been chronicled in various studies and academic literature. Although no known studies published after 2000 have reported any aorta rupture events, patients should be aware of this potentially catastrophic risk.|
|Femoral artery occlusion||Blockage (occlusion) of the femoral artery, where IABP catheters are often inserted, is another potential risk that can lead to a restriction in blood flow to various parts of the body.|
|Groin hematoma||Blood from damaged vessels can collect underneath the skin forming bruises or other, more severe types of hematomas. If severe enough, hematoma may cause other ensuing symptoms and complications.|
|Renal failure||Failure or diminishing functionality of the kidneys can be caused by IABP use in some cases, due possibly to reduced blood flow to the kidneys or a renal artery embolism. Most IABP-related renal failures incidents occur within six months of use of the device.|
|Hemorrhagic stroke||According to the FDA, patients who have an IABP inserted during surgery may be at a higher risk for hemorrhagic stroke due at least in part to anticoagulants used during the insertion of the device. Although the IABP device itself may not cause the stroke, patients should be aware of related risks factors such as this.|
Furthermore, if an IABP is left in place for an extended period of time while inactive (15 minutes or more), there is a risk of blood being caught in the collapsed balloon, which could lead to the development of clots. In 2007, a patient’s IABP catheter was left inserted for an extended period after the pump’s helium supply expired. When the attending nurse removed the catheter later, part of the balloon’s membrane was left behind in the patient’s artery. Despite an emergency operation to retrieve the membrane, the patient died. 2 Fortunately, such situations are rare, but patients and family members should discuss such dangers with their doctors before surgery and during recovery.
Maquet Intra-Aortic Balloon Pumps Recall
In March 2014, the FDA issued a Class I recall of all intra-aortic balloon pumps produced by Maquet Datascope Corporation between January 1, 2003 and June 30, 2011. Class I recalls are the most serious type of recall that the FDA issues, typically reserved for recalls of devices that may have severe health consequence, including fatalities. At least one death has been tied to the defective IABP devices produced during the recall period.
According to the FDA’s safety communication, the company collected as many as 106 failure reports related to their IABP devices before the recall. The defective design was related to an incorrectly shaped retaining ring, which could become detached from the rest of the intra-aortic balloon pump assembly, causing shutdown or overheating if not caught immediately. The device malfunction could then lead to reduced blood flow, possibly causing tissue and organ damage that might result in serious injury or death. 3
Food & Drug Administration. “Classification of Intra-Aortic Balloon Pump (IABP) Devices.” (Dec. 5, 2012). FDA.gov. Accessed Sept. 26, 2014. ↩
Weil, Kathleen M. “On Guard for Intra-aortic Balloon Pump Problems.” (July 2007). Nursing. Accessed Sept. 26, 2014. ↩
Food & Drug Administration. “Maquet Datascope Corporation, Intra-Aortic Balloon Pumps, System 98/98XT, CS100/CS100i, and CS300 – Potential Failure of Fan Assembly May Cause Pumps to Shut Down Without Any Alarm.” (March 21, 2014). FDA.gov. Accessed Sept. 26, 2014. ↩