Artificial Spinal Disc Surgery - Johnson & Johnson began selling Charite Artificial Spinal Discs in 2004. The artificial spinal disc is inserted into the spinal vertebrae column as an alternative to spinal fusion or other serious spinal surgeries. The artificial spinal discs have been linked to failures which actually increased back pain.

Baxter Infusion Pumps - Infusion pumps are devices which administer fluids in ways which would be unreliable or expensive if they were manually given by nurses. They are able to inject controlled amounts of fluid into the body. Sales were stopped for all Baxter Colleague infusion pumps due to battery problems, electronic failures, software glitches and other defects which could cause life sustaining therapy to be interrupted.  The unplanned discontinuation of infused medication can cause serious injury, withdrawal or death.

Bone Screws – The Calaxo bone screw is a bio-absorbable screw inserted into bones that is supposed to promote bone healing while the screw dissolves in the body. In August 2007 the FDA recalled the screws following reports of swelling, pain, pockets of fluid build up, and screw fragmentation.  Patients experienced severe pain and some patients had to have another surgery to replace the screw.

Contact Lens Solution – Complete Moisture PLUS is an "all-in-one" multi-purpose contact lens solution. The company issued a contact solution recall on May 26, 2007 after an alarmingly high number of reported cases of an otherwise rare and very serious eye infection.

Coronary Stents –  Stents are used to open clogged coronary arteries. The Cypher and Taxus stents are coated with a medication that makes reclogging of an artery more difficult. However, the drug-coated Cypher and Taxus stents have been linked an increased risk of blood clots when compared to traditional metal stents. Blood clots that travel to the brain can cause stroke, brain damages, and death.  

Defibrillators & Pacemakers – an implantable defibrillator is a small device that regulates heartbeats. It is often called a Pacemaker. In its simplest terms, when the heart loses rhythm, defibrillators placed under the skin of the chest send out an electrical jolt to shock it back into beating normally.  Companies that manufacture these medical devices announced that design flaws in the wires and battery contributed to malfunctioning defibrillators and pacemakers. 

Duragesic Pain Patches - known as a pain patch or Fen-Phen, the patch is used in patients with moderate to severe chronic pain usually in cancer patients. Each patch contains a three day dose of Fentanyl gel which is designed to release a steady dose through a rate controlled membrane. Fentanyl is an extremely strong pain medication that is 100 times stronger than morphine. The patch has been linked to over 120 overdose deaths due to dosage confusion, mis-prescriptions, and misuse. 

Enteryx GERD device – Exnteryx is a medical device that is permanently implanted into the wall of the lower esophagus of patients who suffer from acid reflux disease or gastroesophageal reflux disease (GERD). The company has received reports that in rare cases, physicians may inadvertently inject Exnteryx into areas close to the esophagus, including other vital organs. This can result in serious health complications for the patient, including internal bleeding, reduced kidney function, and death.

Flextome Cutting Balloon – The Flextome Cutting balloon is used to clear coronary arteries of plaque in  angioplasty surgery. The balloon has micro-blades that scrape away at the plaque build up in the coronary arteries when the balloon is inflated. The device has had problems breaking apart when the device is withdrawn from the body at the end of surgery. 

Guidant Ancure Stent – An endovascular stent is a tube that reinforces a weak spot in an artery. A vascular surgeon inserts the graft to repair the aneurysms. Guidant stents have been linked with 12 deaths and dozens of serious injuries. Guidant Corp. plead guilty to ten felony counts for concealing that the Ancure Device failed in 2,686 patients, including twelve who died and fifty-seven who required additional surgeries to repair problems. The medical device maker will pay $92.4 million in fines, a record penalty for failing to report malfunctions to regulators.

Hernia Repair Patch – The Bard Kugel Hernia patch consists of two layers of synthetic mesh surrounded by a flexible plastic “memory-recoil ring," which is implanted at the site of a hernia. The ring then springs into place, allowing the hernia to heal and regrow around the flattened patch. Reports came in that the rings in some of those devices were breaking, causing injury to patients’ internal organs and tissue from hernia patch side effects, including bowel perforations, bowel obstructions and chronic enteric fistulas. At first the hernia patch company blamed the doctors performing hernia-repair surgery. However, company tests soon revealed that the failures nearly always occurred at the spot where the ring was welded together.

Kidney Dialysis Machines – The Meridian Kidney Dialysis Device is a kidney dialysis machine that removes waste such as urea from the blood.  This is usually need in patients with kidney failure.  The Meridian Dialysis Device was recalled due to twisting and kinking of the blood tubes.

Medtronic Bone Graft – The Bone Graft is a cage brace implanted into the spine which contains a protein that is capable of initiating bone growth. The Medtronic Infuse Bone Graft was approval only to be used in the lumbar spine - or lower back. However, it has come to light that Medtronic pushed doctors to use it in the cervical spine - the neck. This non-approved use in the cervical spine has led to numerous complications including swelling of the face and neck and trouble breathing due to restriction of the airway. Others report difficulty swallowing and speaking.

MRI or MRA Medical Imaging – Gadolinium is a heavy metal ion used as a contrast agent in MRIs (Magnetic Resonance Imaging) and MRAs (Magnetic Resonance Angiogram). Gadolinium is injected into the body to create more visual contrast on the printed films, between normal and abnormal tissue. This enables the doctor to see your condition more clearly. Gadolinium has been linked to several deaths due to a progressive disease known as NSF (nephrogenic systemic fibrosis) or NFD (nephrogenic fibrosing dermopathy) which causes a hardening of the skin and joints.

Omniscan MRI Gadodiamide Contrast Dye - Gadodiamide, marketed as Omniscan is an injection dye given to provide contrast during MRI and MRA tests.  The gadolinium injection has been associated with the development of a painful and debilitating condition for those with kidney disease or impaired renal function. Gadodiamide has also been linked to a severe and debilitating injury among some patients, known as nephrogenic systemic fibrosis (NSF) which causes a hardening and thickening of the skin and other tissue throughout the body, severely restricting movement.

Oral Sodium Phosphate – Fleets Phosphate, Visicol and OsmoPrep are routinely prescribed to cleanse the bowel prior to colonoscopy. These products have a long history of safe use as laxatives, but when taken for bowel cleansing (a purgative dose) they have been associated with serious adverse effects causing severe kidney injury and renal damage. 

Panacryl Sutures – Panacryl sutures are a type of stitches that are used to close a wound in the skin and body.  The sutures are supposed to dissolve and be absorbed by the body.  However, sometimes Panacryl sutures are not absorbed by the body and are rejected by the body causing a higher rate of infection and scar tissue.  Additional surgeries may be necessary to remove the sutures from the infected area. 

ReliOn Insulin Syringes – ReliOn distributed mislabeled insulin syringes which contained 2 ½ times the normal dosage of insulin.  The FDA issued a recall of the U-40 and U-100 syringes which were mislabeled and then distributed to stores.  Receiving an incorrect dosage of insulin from the ReliOn Insulin Syringe could cause serious injury or death. 

Shoulder Pain Pumps – pain pumps which are implanted into the shoulder or knee are used to releave joint pain. While pain pumps will treat the pain, the painkiller medication has been linked to severe cartilage damage. With shoulder pain pumps, this condition is known as postarthroscopic glenohumeral chrondrolysis (PAGCL). This is a devastating condition that causes severe pain and the need for constant medication.  Continued joint and cartilage damage done by pain pumps may require additional surgeries, including shoulder replacement surgery.

Smith and Nephew Knee Implants – Smith and Nephew voluntarily recalled its “cementless” knee implants because the implant did not properly bond to the bone and with time would loosen causing pain, inflammation, and potentially additional surgeries. 

St. Jude Defibrillator Leads – Defibrillator leads are wires that attach the pacemaker to the heart.  Reports have shown that St. Jude Riata Defibrillator Lead wires have malfunctioned and perforated the hearts of some patients.  Further, when a pacemaker wire detaches from the heart, the pacemaker does not function properly leaving the patient at a higher risk for a heart attack. 

St. Jude Symmetry Heart Bypass – In a Symmetry heart bypass, aortic connectors are used instead of stitches. The heart bypass is usually done without placing the patient on a heart/lung machine.  The FDA is aware that use of an aortic connector may create a greater risk for post-operative complications such as graft narrowing, leakage, failed deployment, and occlusion. Many of the symmetry bypass aortic connector patients had to undergo a second coronary bypass procedure to repair the graft and remove the aortic connector device. Many patients suffered medical problems, such as heart attacks, respiratory failure, and even death.

Stryker Hip Implants – The FDA investigated the Stryker manufacturing plant and found numerous violations regarding quality control and bacterial contamination.  Further complaints to the FDA note the hip implant has caused bone fractures due to improper connection and squeaking noises from the hip implant components.    

Synex II Vertebral Body Replacement – The Synex II is an artificial vertebrae that is implanted in the spine to replace damaged vertebrae.  The FDA notes that the device may fail after implantation causing a loss in the vertebral body replacement height. According to the FDA, the failure of the device can lead to nerve injury, severe pain, spinal compression, and the need for additional spinal surgeries.

Vaginal Mesh and Bladder Slings – These are medical devices, which are usually implanted on the vaginal wall to support organs that have dropped from their position and rest on the bladder.  The mesh slings help relieve female stress urinary incontinence (SUI) and pelvic organ prolapse (POP).  The most frequent complications from these vaginal mesh products or bladder slings includes mesh erosion into the vagina, mesh shrinkage or migration, infections, pelvic pain, urinary problems by the return of incontinence or development of urinary retention, pain with sexual relations, neuropathic pain, fistulas and recurrence of prolapsed organs. These complications have led to vaginal scarring and medical conditions that have significantly decreased the quality of life many patients once enjoyed.

Zimmer Durom Hip Replacement System Cups – The Zimmer Durom Hip Replacement is supposed to join to the hip joint by additional bone growth into the top of the specially engineered roughened coating on the back of the hip cup. If the growth of the bone into the coating does not occur, patients typically experience severe pain and are forced to undergo a second surgery to replace the cup and possibly other portions of the hip replacement. However, some estimates of the rate of failure of Durom cups is as high as 1 in 4. In 2008 the company suspended sales of its artificial hip due to the high rate of failure.