Penumbra’s pressing voluntary recall applies to all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex).
Docs use these units to take away blood clots and restore blood move in individuals who have suffered an acute ischemic stroke. The catheter enters the physique by way of a blood vessel within the leg and travels up by way of the neck. As soon as the catheter makes contact with the blood clot inflicting the stroke, docs are in a position to vacuum out the clot and restore blood move.
Penumbra has reported greater than 200 reviews of loss of life, damage, malfunction or different adversarial occasions linked to the JET 7 Xtra Flex.
These reviews included mentions of machine malfunctions, inflicting critical accidents, together with 14 affected person deaths brought on by distal tip injury and growth and rupture following distinction injection.
Legal professionals are at present submitting lawsuits on behalf of injured stroke sufferers and members of the family who misplaced family members after procedures with JET 7 Xtra Flex Catheter.
These lawsuits are within the preliminary levels, and there have been no trials or settlements.
Causes for the Recall
Penumbra issued its pressing voluntary recall due to machine malfunctions and breakage that would trigger accidents and loss of life.
“Penumbra is recalling the JET 7 Xtra Flex as a result of the catheter might turn out to be prone to distal tip injury throughout use. Distal tip injury together with pressurization or distinction injection might lead to potential vessel injury, and subsequent affected person damage or loss of life,” in keeping with Penumbra’s Pressing Voluntary Medical Gadget Recall Notification.
Gadget failure reviews embody “ballooning, growth, rupture, breakage or full separation, and publicity of inner help coils close to the distal tip area of the JET 7 Xtra Flex catheter” in keeping with the U.S. Meals and Drug Administration.
The FDA has offered 510(okay) premarket notification numbers for the recalled units.
In line with the U.S. Meals and Drug Administration, the recalled JET 7 catheters embody:
FDA Actions and Label Warnings
After the clearance of the JET 7 Xtra Flex, the FDA acquired reviews of machine failure. The company prompted Penumbra to subject a notification to well being care suppliers with warnings and precautions to mitigate dangers, in keeping with the FDA’s recall notification.
On July 27, 2020, Penumbra despatched a letter to well being care suppliers with warnings.
“JET 7 Xtra Flex might turn out to be prone to growth or rupture throughout distinction injection as a consequence of distal tip weakening from manipulation towards resistance or use with different producers’ revascularization units. Distal tip growth or rupture might trigger vessel injury and subsequent affected person damage or loss of life,” the letter stated.
The letter warned suppliers to not inject distinction media by way of the JET 7 Xtra Flex. As an alternative, they need to use the information catheter to inject distinction.
The labeling replace didn’t cease reviews of issues with the machine. Some reviews have been associated to suppliers not following directions. The FDA requested that Penumbra take away all JET 7 Further Flex from the market to guard sufferers.
Accidents Folks Are Suing For
Penumbra JET 7 Reperfusion Catheters with Xtra Flex Expertise are related to a number of potential uncomfortable side effects and problems. These embody allergic reactions from distinction media, machine malfunction, loss of life, air embolism, hemorrhage at entry website and an infection.
Accidents in lawsuits are linked to machine malfunction and breakage.
Accidents included in lawsuits embody:
Stroke (cerebral infarction)
Blood vessel injury
What to Do If You’ve Been Injured
In the event you select to file a possible declare towards Penumbra, contact an legal professional instantly. There are closing dates to file an damage declare. As soon as this time restrict passes, you gained’t be capable of search potential compensation for accidents or loss of life related to the JET 7 Xtra Flex Catheter.
Collect all medical information and put together to debate particulars together with your lawyer to see in the event you qualify to file a lawsuit.
The FDA recommends reporting the damage to MedWatch, the FDA Security Data and Antagonistic Occasion Reporting program. This permits the FDA to determine dangers with medical units.
Be sure you focus on the accidents together with your medical supplier and perceive what your choices are for remedy.
Please search the recommendation of a medical skilled earlier than making well being care choices.
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