What’s the Problem?
September 7, 2017 – The “field correction” action applies to 5,049 Datascope intra-aortic balloon pumps models including CS100i, CS100, and CS300. These devices were manufactured from July 1, 2003 to June 16, 2017, according to an FDA recall notice issued June 16, 2017.
FDA said the action was taken after the manufacturer determined there was a potential electrical test failure code. The recall also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP, according to the FDA.
Datascope received at least one report of a patient death due to failure of the balloon pump to initiate therapy. This complaint involved a CS300 IABP that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. An electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve, according to the manufacturer.
Affected Datascope balloon pumps units were distributed in the U.S. and worldwide from March 2003 to December 2013. Units distributed after Dec. 11, 2013, are not affected by the recall. There are about 12,000 affected units sold globally, Datascope said.
Maquet has told end-users that the risk-benefit of using an affected CS100i, CS100 or CS300 IABP should be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available. The company said clinicians should not leave the patient unattended during IABP therapy.
About Class Action Lawsuits
Although we are a nationally recognized class action firm, the Products Liability Litigation Group at our law firm has decided against the filing of a Datascope Balloon Pump Class Action Suit and is currently filing individual claims on behalf of injured individuals and/or their family members who were injured after receiving an intra-aortic balloon pump.
A class action is a type of lawsuit filed with the court on behalf of large group of people or “class” of individuals that have been injured or wronged. The class is represented by the law firm and the case is generally decided upon a single member of the class who is sometimes referred to as the “class representative or class rep.”
Why Our Law Firm Is Filing Individual Lawsuits Opposed To a Class Action
In some instances, a class action may offer some advantages, as they aggregate a large number of individualized claims into one representational lawsuit. The aggregation can increase the efficiency of the legal process, lower the costs of litigation and in some cases offer the solution to a common problem wherein small recoveries do not provide the incentive for any individual or law firm to file an individual lawsuit.
However, a class action suit can also be a detriment to many class members, as they are often forced into a blanket “low ball settlement” and higher attorney fees. At Schmidt & Clark, LLP we understand that our clients are suffering emotionally and economically due to loss of wages and/or high medical bills and we plan to maximize each client’s recovery by filing individual aortic balloon pump lawsuits on their behalf.
Do I Have a Datascope Balloon Pump Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in balloon pump lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one was injured, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit and we can help.