Original Version of Penumbra. Penumbra is initiating a voluntary Field Removal of the original version of its Neuron 6F 070 Delivery Catheter, the U.S. Food and Drug Administration (FDA) just announced. Penumbra has received feedback from some users that these recalled catheters could kink or ovalize in certain anatomical situations.
This kinking and/or ovalization of the catheter lumen can lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued use of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury, or death.
To date, there have been four injury reports, which may be potentially associated with this defect.
Consumers with the older version of 6F Neuron 070 Delivery Catheter, which is being recalled, should stop using and return the device. If your facility is in possession of units with lot numbers F14630 or higher, you may continue to use these units; units with lot numbers F14630 or higher are not affected by this Field Removal Action.
The following product catalog numbers and lot numbers are affected by this Field Removal:
Neuron Delivery Catheter 070 catalog number: PND6F0701058, PND6F0701058M, PND6F070956, and PND6F070956M.
Affected lot numbers include: F13733, F13751, F13773, F13799, F13817, F13826, F13856, F13865, F13880, F13899, F13934, F13960, F13970, F13971, F13980, F13997, F14007, F14028, F14045, F14046, F14047, F14048, F14102, F14103, F14150, F14182, Fself-imposed 14183, F14427, F14482, F14560, and F14629.
Penumbra voluntarily conducted a field removal of the devices after learning about the devices potential to kink or ovalize; the FDA has been apprised of this action. Penumbra is also notifying affected hospitals through detailed Field Removal notification letters requesting that the affected product be returned to Penumbra.
A replacement product will be available for all affected customers. Consumers with questions may contact Penumbra at 1-888-272-4606 or 1-510-748-3200.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax at: www.fda.gov/medwatch/report.htm; by fax at 1-800-FDA-0178; or by regular mail—using postage-paid FDA form 3500 (available at www.fda.gov/MedWatch/getforms.htm)—to MedWatch, 5600 Fishers Lane, Rockville, Maryland, 20852-9787.