Table of contents
- Latest Bard Crurasoft Hernia Patch Lawsuit Updates
- August 23, 2002: FDA Clears the Bard CruraSoft Patch
- What Is Bard Crurasoft Hernia Patch?
- Who May Be Affected?
- Reported Injuries or Damages
- Evidence to Preserve
- Filing Deadlines
- Potential Compensation
- Frequently Asked Questions
- Has the Bard Crurasoft Hernia Patch Been Recalled?
- Is the Bard Crurasoft Hernia Patch Part of a Class Action or MDL?
- Does a Hernia Patch Have to Be Recalled Before I Can File a Lawsuit?
- What Are the Symptoms of a Failing Hernia Patch?
- Who Could Be a Defendant in a Bard Crurasoft Hernia Patch Case?
- Is the Crurasoft Patch the Same as Other Bard Mesh Products Named in Lawsuits?
- References
People implanted with a Bard Crurasoft Hernia Patch during hernia surgery have reported mesh-related problems. These include migration, infection, and bowel obstruction. Lawyers are looking into whether the reported problems could support a claim against Davol, a C.R. Bard unit.
No lawsuit, class action, or joint federal case naming the Crurasoft Patch by name has been filed. The status here is limited to a lawyer review, apart from a separate federal case that covers other Bard mesh products.
This page covers what the Crurasoft Patch treats and what has been reported about it. It also covers what someone hurt after getting one can do next.
Lawsuit at a glance
- Case or litigation name: No lawsuit specific to the Bard Crurasoft Hernia Patch identified
- Defendants: None named in a filed case; C.R. Bard, Inc. and Davol, Inc. are the maker and distributor named in the device’s FDA record
- Court and docket number, when available: No filed case identified for the Bard Crurasoft Hernia Patch specifically
- MDL number, judge, and case count, when an MDL exists: No MDL
- Filing date: No filing yet
- Main allegations: None filed; the mesh-defect theory used against other Bard hernia-mesh products has not been applied to Crurasoft in any known case
- Products or people involved: Bard Crurasoft Hernia Patch (models 0116001 and 0116003), used for the repair of chest wall defects and hernias, including diaphragmatic and hiatal hernias
Latest Bard Crurasoft Hernia Patch Lawsuit Updates
August 23, 2002: FDA Clears the Bard CruraSoft Patch
The FDA cleared the Bard CruraSoft Patch (models 0116001 and 0116003) under premarket notification K022350 [1]. The agency found it substantially equivalent to an existing PTFE mesh used to repair soft-tissue defects. That clearance covers repair of chest wall defects and hernias, including diaphragmatic and hiatal hernias. No lawsuit, recall, or safety alert has followed this device since that 2002 decision.What Is Bard Crurasoft Hernia Patch?
Surgical mesh is a man-made material surgeons place during hernia repair to strengthen weak tissue, according to the FDA [2]. The Bard Crurasoft Patch is one such mesh: a PTFE and ePTFE patch Davol, a C.R. Bard unit, makes. The FDA cleared it in 2002 for diaphragmatic and hiatal hernia repair, one of the chest-wall procedures covered by that clearance.Who May Be Affected?
Bard Crurasoft Hernia Patch is FDA-cleared for diaphragmatic and hiatal hernia repair, part of the device’s broader chest-wall indication. Anyone who got this specific patch during one of those procedures is the group a claim would look at. Surgeons and the FDA link mesh problems, in general, to new or worsening pain in the belly or chest, and to signs of infection. A returning hernia or bowel obstruction can also show up after the first surgery. No recall or lawsuit currently names the Crurasoft Patch by name. A review would rely on the device’s FDA safety record and the reader’s own medical and surgical history. A separate federal mesh case, MDL 2846, covers other Bard mesh products made of a different material [3]. An individual legal review can help confirm whether a specific case may qualify.Think you may qualify?
Schmidt & Clark offers a free, no-obligation review of a potential Bard Crurasoft Hernia Patch case. Requesting a review does not promise that a case qualifies or guarantee any particular outcome.
Start My Free Case Review
Reported Injuries or Damages
The FDA reviewed adverse-event reports and studies on hernia repair with or without mesh. It found pain, infection, hernia return, tissue adhesion, bowel obstruction, bleeding, fistula, fluid buildup (seroma), and perforation to be the most common problems. For repairs done with mesh, the same FDA review also lists mesh shift or shrinkage as an added risk. The FDA says this risk may raise the chance of the other problems listed above. The FDA has not published a Crurasoft-specific case count. A report alone does not prove that one patch caused one injury.Evidence to Preserve
Anyone who thinks a Bard Crurasoft Hernia Patch caused harm should keep the items below:- The implant card or medical record that lists the model number, 0116001 or 0116003, and the date of surgery
- Hospital records that describe how and when the mesh was placed, plus any later surgery
- Scans, lab work, or pathology reports tied to the health problem, including any follow-up tests a doctor ordered
- Notes on every doctor visit, treatment, and hospital stay linked to the symptoms felt
- Photos of any visible problem, such as a wound, bulge, or change in the skin near the surgery site
- Emails, letters, or calls with the surgeon, hospital, or device maker about the patch or recovery
Filing Deadlines
Deadlines for filing a hernia-mesh injury claim come from state law and depend on where you live and when your injury or its diagnosis occurred. Some states start the clock at diagnosis instead of surgery. A claim can be barred by a missed filing deadline no matter how strong the medical facts are. Anyone who suspects a Crurasoft-related injury should check with a lawyer promptly.Potential Compensation
A hernia-mesh injury claim over the Crurasoft Patch, if one is later filed, could seek damages courts allow in device-injury cases. Those could include medical bills, lost pay, and pain and suffering. No court has ruled on, and no deal has settled, a claim that names the Bard Crurasoft Hernia Patch. No dollar figure can be tied to this specific device as of the read date. Compensation amounts vary by case. Past results do not guarantee future outcomes. Potential compensation in a future claim would still need to be set by a lawyer, not estimated here.Frequently Asked Questions
Has the Bard Crurasoft Hernia Patch Been Recalled?
No, the Bard Crurasoft Hernia Patch has not been recalled. The FDA has announced no recall, safety alert or market withdrawal for this patch. The device’s own FDA clearance record confirms this, as of September 24, 2026.Is the Bard Crurasoft Hernia Patch Part of a Class Action or MDL?
No MDL or class action currently covers the Bard Crurasoft Hernia Patch. A federal mesh case in the Southern District of Ohio, MDL 2846, overseen by Judge Edmund A. Sargus, Jr., covers other Bard products made of polypropylene, a different material from Crurasoft’s PTFE.Does a Hernia Patch Have to Be Recalled Before I Can File a Lawsuit?
No, a hernia patch does not have to be recalled before you can file a lawsuit. Even without a recall, a claim over the Crurasoft Patch could still rely on FDA adverse-event data and medical records. It could also rely on the device’s complication profile, as of September 24, 2026.What Are the Symptoms of a Failing Hernia Patch?
Symptoms of a failing hernia patch include new or worsening pain at the repair site and redness or fever that suggests infection. A bulge can signal the hernia has returned, and severe pain, nausea, or vomiting can signal bowel obstruction.Who Could Be a Defendant in a Bard Crurasoft Hernia Patch Case?
The likely defendants in a Bard Crurasoft Hernia Patch case would be C.R. Bard, Inc. and its Davol, Inc. subsidiary, the maker and distributor named on the device’s FDA clearance record. Bard has been part of Becton, Dickinson and Company since 2017.Is the Crurasoft Patch the Same as Other Bard Mesh Products Named in Lawsuits?
No, the Crurasoft Patch is not the same as other Bard mesh products named in lawsuits. It is a PTFE device, unlike the polypropylene products in MDL 2846, and its maker, C.R. Bard, only joined Becton, Dickinson and Company in 2017.References
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K022350
- https://www.fda.gov/medical-devices/implants-and-prosthetics/surgical-mesh-used-hernia-repair
- https://www.ohsd.uscourts.gov/multidistrict-litigation-2846


