On December 15, 2020, the U.S. Food and Drug Administration (FDA) announced that medical device manufacturer Penumbra had issued an urgent, voluntary recall for all of their JET 7 Xtra Flex catheters and JET 7 MAX configuration delivery devices. The recall was issued for all lot numbers, all models and all manufacturing dates and was due to medical device reporting which showed over 200 incidences of injury, failure or malfunction had resulted in at least 14 deaths.
Malfunction of the Penumbra catheter has resulted in blood vessel rupture due to rapid expansion of the catheter tip, breakage of the catheter tip or puncture of the blood vessel due to catheter system malfunction. In these cases, immediate hemorrhage may occur, leading to patient death.
At least 14 deaths and 200 injuries have been associated with the use of these catheters, possibly more as the FDA’s MAUDE system of reporting adverse events is voluntary and not required by law.
About Penumbra Xtra Flex Catheter
Penumbra JET 7 Xtra Flex catheter and JET 7 MAX configuration (MAX Delivery Device) are used to restore blood flow by removing blood clots within 8 hours of symptom onset in patients who are ineligible for IV tissue plasminogen activator or those who failed IV t-PA therapy.
The JET 7 catheter is an aspiration thrombectomy device which is inserted through a small incision in a large artery on the wrist or hip. The catheter is “driven” to travel through the blood vessels using physician operated technology, where it is used to remove a clot that is occluding blood flow to the brain.
Aspiration thrombectomy is performed about 50,000 times per year in the U.S. Though other companies manufacture aspiration catheters, about 80% of these procedures use Penumbra technology.
The Penumbra Xtra Flex Catheter device was approved in July 2019 and has made up about 30% of Penumbra’s aspiration catheter sales in the 18 months it was on the market. Which may mean it is estimated to have been used in about 10,000 procedures. The recall involves over 20,000 devices or all of the remaining stock of Penumbra JET 7 Xtra Flex Catheters and JET 7 MAX delivery devices.
Prior Difficulties with Penumbra Xtra Flex Catheter
In August 2020, the FDA required modification of the safety instructions regarding use of intravenous contrast during an interventional cardiac procedure performed with the JET 7 Xtra Flex Catheter. The use of IV contrast or dye was reportedly associated with an increased risk of complications.
Penumbra had issued a July 2020 Notification to Healthcare Providers warning against using the catheter to inject IV contrast media during the procedures.
Penumbra Device Malfunctions
The FDA’s reporting system “MAUDE” indicates that over 200 medical device reports have been filed regarding the Penumbra JET 7 Xtra Flex device, detailing malfunctions that may have resulted in serious injury.
Device failures included:
- Sudden ballooning
- Sudden expansion
- Exposure of internal support coils
Any of these events may have led to vessel damage or puncture or procedure failure with resulting complications that may include:
- Vessel damage
- Cerebral infarction
At least 14 deaths have been directly associated with failure of the Penumbra JET 7 Xtra Flex Catheter and dozens of additional injuries may have occurred.
A number of people may be considering Penumbra catheter lawsuits which may provide compensation for injuries, wrongful death, or other complications. People or loved ones of those who underwent an aspiration thrombectomy and experienced injury, complications or died due to the procedure should seek legal advice.
- Penumbra’s Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage, U.S. Food and Drug Administration (01/29/2021)
- Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers, U.S. Food and Drug Administration (12/15/2020)