Datascope Intra-Aortic Balloon Pump Lawsuit | 2025 Latest Updates

What’s the Problem?

Legal action has emerged against Datascope Corp./MAQUET following a Class I recall of 12,000 intra-aortic balloon pump (IABP) units due to device failures that can cause serious adverse health consequences including death.

The primary allegations focus on defects in CS100i, CS100, and CS300 models manufactured from July 1, 2003 to June 16, 2017, which can fail to initiate therapy or stop functioning during critical cardiac support procedures [1].

At least one patient death has been reported due to a false blood detection alarm, with the device failing to provide life-saving circulatory support when patients were in critical condition.

The FDA expanded the recall to include approximately 12,000 units distributed globally between March 23, 2003, and December 11, 2013.

Datascope balloon pump lawsuit claims center on the manufacturer’s alleged failure to address known defects that prevent proper device operation during life-threatening cardiac emergencies.

Latest Datascope Intra-Aortic Balloon Pump Recall Updates

• February 2019 – Getinge/Maquet announced development of new software to address device failure issues, though this does not address potential injuries to patients or harm to families of those who may have died from cardiovascular complications caused by device malfunctions [2].
• May 2018 – The FDA issued a Class I recall for thousands of CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps (IABPs) manufactured by Maquet Datascope Corp. due to fluid ingress that could cause corrosion, short-circuiting, power failure, and sudden device shutdown, potentially requiring immediate patient resuscitation. The recall affected devices distributed between March 2012 and April 2018. Getinge/Maquet performed a correction in May 2018 to address this safety issue [3].
• 2017 – FDA designated expanded recall as “Class I,” the highest level of recall, involving all units manufactured before June 30, 2013, including devices distributed in the U.S. from March 2003 to December 11, 2013, affecting approximately 12,000 units globally [4].
• 2003-2017 – Datascope manufactured defective balloon pump models CS100i, CS100, and CS300 with known electrical test failure issues, including failure code #58 that led to at least one documented patient death when device failed to initiate life-saving therapy [5].

FDA Reports and Statistics

The FDA has issued comprehensive safety alerts and recalls for Datascope intra-aortic balloon pumps affecting thousands of devices worldwide.

The Class I recall designation represents the most serious level of FDA action, reserved for devices that pose immediate and serious adverse health consequences.

Approximately 12,000 balloon pump units were affected globally, with distribution occurring between March 23, 2003, and December 11, 2013.

The initial recall involved 5,049 devices, which was later expanded to include all units manufactured before June 30, 2013.

Device failures have been specifically linked to electrical test failure code #58, which prevents proper therapy initiation in critically ill patients requiring circulatory support.

The FDA has documented at least one patient death directly attributable to device malfunction during emergency cardiac care.

Datascope Balloon Pump Injuries & Side Effects

Datascope intra-aortic balloon pump failures have resulted in serious complications and deaths when devices malfunction during critical cardiac support procedures.

• Device Failure Consequences: Immediate cessation of life-saving circulatory support, failure to initiate therapy when patients require emergency cardiac assistance, and sudden device shutdowns during critical procedures.
• Cardiovascular Complications: Worsening heart failure, cardiovascular collapse, acute coronary syndrome progression, and death from lack of mechanical circulatory support.
• Emergency Complications: Need for emergency resuscitation, requirement for alternative cardiac support devices, and complications from interrupted therapy during critical cardiac procedures.
• Fatal Outcomes: Patient deaths due to device failure during emergency cardiac support, false alarm-related therapy interruptions, and cardiovascular complications when backup support is unavailable.

Do You Qualify for a Datascope Balloon Pump Lawsuit?

You may qualify for a Datascope intra-aortic balloon pump lawsuit if:

• You or a loved one received treatment with Datascope CS100i, CS100, or CS300 balloon pumps between 2003 and 2017.
• You experienced device failure, therapy interruption, or cardiovascular complications during IABP treatment.
• The device malfunction resulted in serious injury, prolonged hospitalization, or death.
• You can provide medical documentation linking complications to Datascope balloon pump failure.
• Treatment occurred with devices manufactured before June 30, 2013, that were subject to the Class I recall.

Evidence Required for a Datascope Balloon Pump Lawsuit

• Medical Documentation: Hospital records, cardiac care unit reports, device monitoring records, and documentation of balloon pump malfunctions during treatment.
• Device Evidence: Product identification, serial numbers, model information (CS100i, CS100, CS300), and documentation of device placement and operation.
• Treatment Records: Records of cardiovascular complications, emergency interventions, alternative cardiac support measures, and outcomes following device failure.
• Expert Medical Testimony: Cardiac specialist assessments, device failure analysis, and medical expert opinions on causation between device malfunction and patient injuries.

Damages You Can Recover

• Medical Expenses: Emergency cardiac care, intensive care unit costs, alternative cardiac support devices, prolonged hospitalization, and ongoing cardiovascular treatment.
• Lost Wages: Income lost due to extended hospitalization, cardiovascular complications, disability, or death of family member.
• Pain and Suffering: Compensation for physical pain, emotional trauma, and reduced quality of life from device-related cardiovascular complications.
• Punitive Damages: Additional compensation to punish Datascope for releasing defective life-support devices and failing to address known safety issues.

Datascope Balloon Pump Recall Information

• Initial Recall Date: 2017 (expanded from earlier recalls)
• Recall Classification: Class I (most serious FDA recall level)
• Devices Affected: Datascope CS100i, CS100, and CS300 intra-aortic balloon pumps.
• Units Recalled: Approximately 12,000 devices globally
• Manufacturing Period: July 1, 2003 to June 16, 2017 (expanded recall covers March 23, 2003 to December 11, 2013).
• Manufacturer: Datascope Corp./MAQUET (Getinge)
• Recall Reason: Device failures causing therapy interruption, false blood detection alarms, and inability to initiate life-saving circulatory support.
• Additional Recalls: CARDIOSAVE hybrid IABPs recalled in May 2018 for fluid infiltration causing device shutdown.

The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death .- FDA.

Statute of Limitations for Datascope Balloon Pump Lawsuits

The statute of limitations for medical device lawsuits varies by state, typically ranging from 1-6 years from the date of injury discovery.

In Datascope balloon pump cases, the limitations period generally begins when device-related complications are diagnosed and linked to device malfunction.

• Most States: 2-3 years from date of injury discovery.
• Discovery Rule: May extend deadlines when device failures are not immediately apparent as the cause of complications.
• Wrongful Death Cases: Separate statutes apply, typically 2-3 years from date of death.
• Product Liability Claims: May have different limitation periods based on when device defects became known through recalls.

Given the critical nature of cardiac device failures and the complexity of establishing causation, consultation with legal counsel is essential to determine specific filing deadlines.

FAQs

1. What models of Datascope balloon pumps are involved in the recall?

The recall affects CS100i, CS100, and CS300 models manufactured from July 1, 2003 to June 16, 2017, as well as any System 98 or System 98XT IABP converted to CS100i or CS300 models. Approximately 12,000 units were affected globally.

2. How many deaths have been reported from Datascope balloon pump failures?

At least one patient death has been documented due to a false blood detection alarm preventing the device from providing life-saving circulatory support. Additional deaths may have occurred due to device failures during critical cardiac procedures.

3. What specific defects cause Datascope balloon pumps to fail?

Device failures include electrical test failure code #58, false blood detection alarms, and defective solenoid driver boards. These defects prevent proper therapy initiation or cause sudden device shutdowns during critical cardiac support procedures.

4. Are newer Datascope balloon pumps still dangerous?

Units distributed after December 11, 2013, are not included in the Class I recall, though the manufacturer announced software development in 2019 to address ongoing issues. Patients should discuss device safety with their healthcare providers.

5. What compensation is available for Datascope balloon pump injuries?

Compensation may include medical expenses for emergency cardiac care, lost wages, pain and suffering, and punitive damages. Cases involving death or permanent cardiovascular complications may result in substantial settlement amounts.

6. How do I know if a Datascope balloon pump caused my complications?

Medical records documenting device malfunctions, false alarms, or therapy interruptions during your cardiac treatment can establish causation. Hospital device monitoring records and cardiac specialist assessments are particularly important evidence.

7. Can family members file wrongful death claims for balloon pump deaths?

Yes, surviving family members can pursue wrongful death claims when Datascope balloon pump failures contribute to patient deaths during cardiac emergencies. These claims may include funeral expenses, lost income, and emotional suffering compensation.

8. What should I do if I’m currently being treated with a Datascope balloon pump?

Discuss device safety with your cardiac care team immediately and ensure backup cardiac support is available. Document any device malfunctions or alarms and contact our attorneys for legal evaluation of potential compensation rights.

9. How long do Datascope balloon pump lawsuits typically take?

Medical device lawsuits typically take 1-3 years to resolve, depending on case complexity and medical evidence requirements. Cases involving critical cardiac device failures may require extensive expert testimony and medical documentation.

10. What evidence do I need to prove device failure caused my injuries?

Hospital records, device monitoring logs, cardiac care documentation, and medical expert testimony establishing the link between device malfunction and cardiovascular complications. Serial numbers and model identification help confirm recalled device involvement.

Contact us today to speak to experienced defective medical device attorneys to learn more about your legal rights.

Get a Free Datascope Intra-Aortic Balloon Pump Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for Datascope balloon pump injuries. Most states allow only 2-3 years from the date of injury discovery to file medical device lawsuits.

At Schmidt & Clark, we provide:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees for legal representation
• Payment only if we win your case through settlement or trial verdict
• Experienced legal team with cardiac device litigation experience

Our attorneys understand the complex medical and legal issues involved in cardiac device litigation. We work with cardiovascular specialists and medical experts to establish causation and fight for maximum compensation for our clients.

Contact our law firm immediately for your free case evaluation. Do not delay – legal deadlines are strict and evidence preservation is critical for building a strong case.

References

1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/datascope-corpmaquet-issues-worldwide-voluntary-recall-system-cs100-cs100i-and-cs300-intra-aortic
2. https://content.govdelivery.com/accounts/USFDA/bulletins/36d9ba5
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=164199
4. https://www.dicardiology.com/content/fda-announces-recall-maquet-intra-aortic-balloon-pumps
5. https://medtechintelligence.com/news_article/following-patient-death-datascope-performs-field-correction-intra-aortic-balloon-pumps/