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Table Of Contents
- CloverSnare Vascular Retrieval Snare Lawsuit Overview
- Latest CloverSnare Lawsuit Updates
- FDA Reports and Statistics
- CloverSnare Injuries & Side Effects
- Do You Qualify for a CloverSnare Lawsuit?
- CloverSnare Recall Information
- Statute of Limitations for CloverSnare Lawsuits
- FAQs
- 1. What causes the CloverSnare loop to separate from the shaft?
- 2. How many CloverSnare devices were recalled by the FDA?
- 3. What medical complications can result from CloverSnare device failure?
- 4. Do I have a case if my CloverSnare procedure was successful despite device issues?
- 5. What compensation is available for CloverSnare injuries?
- 6. How do I prove that Cook Medical’s CloverSnare caused my injuries?
- 7. Are there alternative devices to the CloverSnare for vascular procedures?
- 8. Can I file a lawsuit if my CloverSnare procedure occurred before the recall?
- 9. What is the typical timeline for CloverSnare lawsuit resolution?
- 10. Do I need the original CloverSnare device to file a lawsuit?
- Get a Free CloverSnare Vascular Retrieval Snare Lawsuit Evaluation With Our Lawyers
CloverSnare Vascular Retrieval Snare Lawsuit Overview
Legal action has been initiated against Cook Medical for injuries caused by the CloverSnare 4-Loop Vascular Retrieval Snare.
The primary allegations focus on design defects that cause the loop to detach from the handle, resulting in device malfunction and patient injury.
At least 6 reports of loop separation have been documented, with 4 cases requiring surgical removal of the separated snare components.
The FDA issued a recall of approximately 700 devices due to the potential for loop detachment, which can lead to embolization and necessitate emergency surgical intervention.
CloverSnare lawsuit claims center on Cook Medical’s alleged failure to adequately warn healthcare providers and patients about the risk of device separation during use.
Latest CloverSnare Lawsuit Updates
- August 27, 2014 – FDA announced Cook Medical’s recall of approximately 700 CloverSnare 4-Loop Vascular Retrieval Snare devices (model numbers VRS-6.0-9.0) due to potential loop separation from the shaft. The recall was initiated on July 10, 2014, following reports of device malfunction during vascular procedures [1].
- July 2014 – Cook Medical documented at least 6 cases of loop snare separation from the shaft during clinical use, with 4 cases requiring surgical intervention to retrieve the separated snare components. The malfunctions occurred when lateral force was applied to change the retriever’s shape during procedures [2].
- March 2013 to July 2014 – Affected CloverSnare devices were distributed to healthcare facilities across multiple countries including the U.S., Canada, and European nations. The recalled devices were manufactured between August 2012 and August 2013 [3].
FDA Reports and Statistics
The FDA recall notice documented specific safety concerns related to the CloverSnare 4-Loop Vascular Retrieval Snare, affecting approximately 700 devices distributed internationally.
The recall covered devices manufactured over a 12-month period and distributed across 12 countries including the United States, Canada, and major European markets.
Clinical reports identified device separation occurring during routine vascular procedures when lateral force was applied to modify the snare’s configuration.
The malfunction rate resulted in surgical intervention requirements for the majority of documented cases, creating additional patient risk and healthcare costs.
The FDA classified this as a medical device recall due to the potential for serious patient harm from embolization and the need for emergency surgical removal of device fragments.
CloverSnare Injuries & Side Effects
CloverSnare device malfunctions have resulted in serious complications requiring immediate medical intervention and additional surgical procedures to address device failures.
- Device Embolization: Separated snare components traveling through the vascular system, potentially causing blockages and tissue damage.
- Emergency Surgery Requirements: Need for immediate surgical procedures to retrieve separated device components from the vascular system.
- Loss of Device Function: Complete failure of the retrieval device during critical vascular procedures, compromising patient care.
- Procedural Complications: Extended procedure times, increased anesthesia exposure, and additional medical interventions due to device failure.
Do You Qualify for a CloverSnare Lawsuit?
You may qualify for a CloverSnare lawsuit if:
- You underwent a vascular procedure using the CloverSnare 4-Loop Vascular Retrieval Snare between March 2013 and July 2014.
- You experienced serious complications including device separation, embolization, or emergency surgical removal.
- The device malfunction required additional medical treatment, surgery, or extended hospitalization.
- You can provide medical documentation linking your injuries to CloverSnare device failure.
- Your procedure involved Cook Medical CloverSnare model numbers VRS-6.0-9.0.
Evidence Required for a CloverSnare Lawsuit
- Medical Documentation: Hospital records, surgical reports, procedure notes, and documentation of device malfunction during vascular procedures.
- Device Evidence: Product identification, lot numbers, model numbers, and documentation of CloverSnare use during your procedure.
- Procedural Records: Operative reports, imaging studies, and medical records showing device separation or embolization.
- Treatment Documentation: Records of additional surgeries, complications, and ongoing medical care related to device failure.
Damages You Can Recover
- Medical Expenses: Emergency surgery costs, additional procedures, extended hospitalization, and ongoing medical care related to device complications.
- Lost Wages: Income lost due to extended recovery, additional surgeries, or complications from device failure.
- Pain and Suffering: Compensation for physical pain, emotional trauma, and reduced quality of life from device-related complications.
- Punitive Damages: Additional compensation to punish Cook Medical for releasing allegedly defective medical devices.
CloverSnare Recall Information
- Recall Date: August 26, 2014 (initiated July 10, 2014)
- Devices Affected: CloverSnare 4-Loop Vascular Retrieval Snare, model numbers VRS-6.0-9.0
- Units Recalled: Approximately 700 devices
- Manufacturer: Cook Medical
- Manufacturing Period: August 2012 to August 2013
- Distribution Period: March 8, 2013 to July 1, 2014
- Countries Affected: United States, Canada, Switzerland, Sweden, Spain, Italy, Ireland, Great Britain, Germany, Denmark, Belgium, and Austria
- Recall Reason: Potential for loop separation from shaft, causing device malfunction and requiring surgical removal.
Also Read: Smiths Medical ProPort Implantable Port Lawsuit
Statute of Limitations for CloverSnare Lawsuits
The statute of limitations for medical device lawsuits varies by state, typically ranging from 1-6 years from the date of injury or discovery of device-related harm.
In CloverSnare cases, the limitations period generally begins when the device malfunction is identified and linked to patient injury.
- Most States: 2-3 years from date of injury discovery
- Discovery Rule: May extend deadlines when device defects are not immediately apparent
- Product Liability Claims: May have different limitation periods based on when device failures became known
- Wrongful Death Cases: Separate statutes apply, typically 2-3 years from date of death
Given the technical nature of medical device failures and the time required to establish causation, consultation with legal counsel is essential to determine specific filing deadlines.
FAQs
1. What causes the CloverSnare loop to separate from the shaft?
The separation occurs when lateral force is applied to the snare during procedures to change the shape of the retriever. This design defect has been documented in at least 6 cases, with 4 requiring surgical intervention to retrieve separated components.
2. How many CloverSnare devices were recalled by the FDA?
The FDA announced the recall of approximately 700 CloverSnare 4-Loop Vascular Retrieval Snare devices (model numbers VRS-6.0-9.0) manufactured between August 2012 and August 2013.
3. What medical complications can result from CloverSnare device failure?
Complications include device embolization, loss of device function during procedures, and the need for emergency surgery to retrieve separated snare components from the vascular system.
4. Do I have a case if my CloverSnare procedure was successful despite device issues?
You may still have a case if you experienced device malfunction, even if the overall procedure was ultimately successful. Additional interventions or complications due to device failure may support legal claims.
5. What compensation is available for CloverSnare injuries?
Compensation may include medical expenses for additional surgeries, lost wages, pain and suffering, and punitive damages. The amount depends on the severity of complications and impact on your health.
6. How do I prove that Cook Medical’s CloverSnare caused my injuries?
Medical records documenting device separation, surgical reports, and expert medical testimony can establish causation. Hospital records showing device malfunction during your procedure are particularly important evidence.
7. Are there alternative devices to the CloverSnare for vascular procedures?
Yes, other vascular retrieval devices are available from different manufacturers. Your healthcare provider can recommend suitable alternatives for vascular retrieval procedures.
8. Can I file a lawsuit if my CloverSnare procedure occurred before the recall?
Yes, you may file a lawsuit for procedures that occurred before the official recall date, particularly if the device exhibited known defects that Cook Medical should have disclosed earlier.
9. What is the typical timeline for CloverSnare lawsuit resolution?
Medical device lawsuits typically take 1-3 years to resolve, depending on case complexity, number of plaintiffs, and defendant cooperation. Some cases may settle earlier while others require extensive litigation.
10. Do I need the original CloverSnare device to file a lawsuit?
While having the device strengthens your case, medical records documenting device use and malfunction can provide sufficient evidence. Hospital procedure records typically identify specific devices used during surgery.
See more about defective medical devices lawsuits.
Get a Free CloverSnare Vascular Retrieval Snare Lawsuit Evaluation With Our Lawyers
Time is limited to pursue legal action for CloverSnare device 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 medical device litigation experience
Our attorneys understand the complex medical and legal issues involved in CloverSnare litigation. We work with medical experts and vascular specialists 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
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129007
- https://www.dicardiology.com/content/cook-recalls-cloversnare-4-loop-vascular-retrieval-snare-due-risk-loop-separating-shaft
- https://www.cookmedical.com/newsroom/cloversnare-4-loop-vascular-retrieval-snare-recall-2/