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Table Of Contents
- Catheter Lawsuit Overview
- Latest Catheter Lawsuit Updates
- FDA Reports and Statistics
- Catheter Injuries & Side Effects
- Do You Qualify for a Catheter Lawsuit?
- Catheter Recall Information
- Statute of Limitations for Catheter Lawsuits
- FAQs
- 1. What types of catheters have been recalled?
- 2. How do I know if my catheter was recalled?
- 3. What complications indicate a potential catheter defect?
- 4. How much compensation can I receive from a catheter lawsuit?
- 5. Can I file a lawsuit if my family member died due to a defective catheter?
- 6. How long does a catheter lawsuit typically take?
- 7. Is this a class action lawsuit or an individual claim?
- 8. What costs will I incur to file a catheter lawsuit?
- 9. Do I need to testify in court for a catheter lawsuit?
- 10. How can I check if there are other lawsuits against my catheter manufacturer?
- Get a Free Catheter Recall Lawsuit Evaluation With Our Lawyers
Catheter Lawsuit Overview
Catheter lawsuits target manufacturers whose defective medical devices have caused severe injuries and deaths.
Primary allegations include design and manufacturing defects leading to catheter rupture, breakage, and separation during procedures.
The FDA has received over 200 medical device reports related to certain catheters, including 20 reports of patient deaths.
Multiple catheter recalls have been initiated, including Class I recalls indicating substantial risk of serious injury or death.
Latest Catheter Lawsuit Updates
- March 2025: Teleflex is addressing safety concerns after the FDA’s 2024 Class I recall of Arrow FiberOptix and UltraFlex catheter kits due to serious complications, including injuries and deaths. While the Venture Catheter recall is closed, Teleflex remains under scrutiny as new complications are reviewed [1].
- January 2025: Penumbra faces mounting litigation related to its JET 7 Xtra Flex Catheter, with plaintiffs alleging the company knew of design flaws before catastrophic patient injuries occurred [2].
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June 2024: The FDA confirmed the recall of Teleflex’s Arrow FiberOptix and UltraFlex catheters due to a defect linked to 31 injuries and 3 deaths. The Class I recall warns of potential blood loss or arterial damage and advises healthcare professionals to inspect affected devices for overtwisting before use [3].
FDA Reports and Statistics
According to FDA MAUDE database reports:
- Over 200 medical device reports associated with the Penumbra JET 7 Xtra Flex catheter.
- At least 20 confirmed patient deaths linked to catheter failures.
- 4,679 potentially defective Venture Catheters distributed throughout the United States.
- Multiple Class I recalls issued between 2020-2024 for various catheter products.
The FDA has taken regulatory action by issuing urgent recall notices and safety communications warning healthcare providers of the serious risks posed by these devices [4].
Catheter Injuries & Side Effects
Defective catheters can cause severe and potentially fatal complications, requiring immediate medical intervention.
- Vascular Damage: Internal bleeding and blood vessel rupture requiring emergency procedures.
- Neurological Injury: Stroke due to arterial rupture or blood clots.
- Organ Complications: Damage to heart, lungs, kidneys or other vital organs.
- Embolism: Blood clots caused by catheter fragments leading to blocked blood flow.
- Surgical Emergencies: Catheter tip breakage requiring additional surgical intervention.
Do You Qualify for a Catheter Lawsuit?
You may qualify for a catheter lawsuit if:
- You underwent a procedure involving a Penumbra JET 7 Xtra Flex Catheter, Venture Catheter, or other recalled catheter device.
- You experienced serious complications such as internal bleeding, stroke, organ damage, or blood clots.
- Your injuries required hospitalization or additional medical treatment.
- You have medical documentation linking your injuries to catheter use.
Evidence Required for a Catheter Lawsuit
- Medical records documenting the procedure where the catheter was used.
- Hospital records showing complications or injuries following the procedure.
- Information about the specific catheter model and manufacturer.
- Documentation from healthcare providers linking your injuries to catheter failure.
Damages You Can Recover
- Medical expenses for additional treatments and surgeries.
- Lost wages and diminished earning capacity.
- Pain and suffering compensation.
- Punitive damages against manufacturers in cases of gross negligence.
Catheter Recall Information
Penumbra Catheter Recall
Penumbra Inc. recalled the following catheters due to high risk of serious injury or death:
- Penumbra JET 7 Xtra Flex Catheter (FDA Cleared: June 16, 2019, under K190010)
- Penumbra JET 7MAX Configuration (Cleared: February 27, 2020, under K191946)
“We received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunction. Device failure modes reported in the MDRs include ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.”–FDA Statement in The Recall Letter.
Venture Catheter Recall
Teleflex’s subsidiary, Vascular Solutions, recalled 3 lots of Venture Catheters affecting:
- Venture Rapid Exchange Catheter (Product Code: 5820)
- Venture Over-the-Wire Catheter (Product Code: 5821)
- Venture Coronary Sinus Catheter (Product Code: 5822)
The FDA classified this as a Class I recall due to excess material inside the catheter tip that can break off and cause embolism [5].
Statute of Limitations for Catheter Lawsuits
The statute of limitations for filing a catheter lawsuit varies by state but typically ranges from 1-3 years from the date of injury or from when you discovered the injury was linked to a defective catheter.
Some states have specific medical device lawsuit timeframes that may differ from standard personal injury statutes [6].
Related Articles
FAQs
1. What types of catheters have been recalled?
Recent recalls include Penumbra JET 7 Xtra Flex, Penumbra JET 7MAX, and Teleflex’s Venture Catheters (including Rapid Exchange, Over-the-Wire, and Coronary Sinus models). Always check the FDA website for the most current recall information [7].
2. How do I know if my catheter was recalled?
You can check the FDA website for recall alerts, consult your healthcare provider, or contact our legal team for a free case evaluation to determine if your catheter was subject to a recall.
3. What complications indicate a potential catheter defect?
Complications that may indicate a defective catheter include unexpected bleeding, stroke symptoms, severe pain during or after the procedure, blood clots, or infection at the insertion site.
4. How much compensation can I receive from a catheter lawsuit?
Compensation varies based on injury severity, medical expenses, lost wages, and other factors. Some medical device lawsuits have resulted in settlements ranging from tens of thousands to millions of dollars [8].
5. Can I file a lawsuit if my family member died due to a defective catheter?
Yes, immediate family members can file a wrongful death lawsuit if a loved one died due to a defective catheter. These cases may include compensation for medical expenses, funeral costs, lost income, and loss of companionship.
6. How long does a catheter lawsuit typically take?
Catheter lawsuits typically take 1-3 years to resolve, depending on case complexity, evidence available, and whether the case settles or goes to trial [9].
7. Is this a class action lawsuit or an individual claim?
Most catheter lawsuits are handled as individual claims or as part of a multidistrict litigation (MDL), allowing for individual assessment of damages while efficiently managing similar cases together.
8. What costs will I incur to file a catheter lawsuit?
Our firm handles catheter lawsuits on a contingency fee basis, meaning you pay nothing upfront and attorney fees are only collected if we win your case.
9. Do I need to testify in court for a catheter lawsuit?
While many cases settle without court appearances, you should be prepared to testify if your case goes to trial. Our legal team will thoroughly prepare you for any required testimony.
10. How can I check if there are other lawsuits against my catheter manufacturer?
Contact our legal team for a comprehensive case evaluation. We track all active litigation against catheter manufacturers and can inform you about similar cases nationwide.
Get a Free Catheter Recall Lawsuit Evaluation With Our Lawyers
Time is limited to pursue legal action for catheter injuries. Most states allow only 1-3 years from the date of injury to file a claim, and this window may be closing rapidly in your case.
Our legal team at Schmidt Clark, LLP offers:
- Free, confidential case evaluations
- No upfront costs or attorney fees
- Payment only if we win your case
Don’t delay taking action that could secure the compensation you deserve. Contact us today to protect your legal rights.
References
- https://www.acc.org/Latest-in-Cardiology/Articles/2024/06/18/20/09/FDA-Update
- https://www.consumernotice.org/legal/penumbra-jet-7-xtra-flex-catheter-lawsuits/
- https://www.medtechdive.com/news/teleflex-catheter-kit-recall-injuries-deaths/718963/
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- https://www.fda.gov/medical-devices/medical-device-recalls/vascular-solutions-recalls-venture-catheters
- https://www.law.cornell.edu/wex/statute_of_limitations
- https://www.fda.gov/medical-devices/medical-device-recalls
- https://www.uscourts.gov/statistics-reports/medical-device-settlements
- https://www.americanbar.org/groups/litigation/committees/products-liability/