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43 reported ongoing
45 records in this archive. Latest source date May 13, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of ord...
Class IIReported ongoing
Distribution: Worldwide distribution.
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgica...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, ...
Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Pat...
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, TX, WA, WI.
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
Class IIReported ongoing
Distribution: Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, ...
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portu...
Software issues were identified in application version 2.x.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Software issues were identified in application version 2.x.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Software issues were identified in application version 2.x.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Software issues were identified in application version 2.x.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
Class IIReported ongoing
Distribution: International distribution to the countries of Germany, UK, and Israel.
The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, MD, MI, MN, MO, NC, NJ, OH, PA, SC, TX, VA, and WA. The countries of Austria, Belgium, Denmark, F...
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of Mississippi.
Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
Class IIReported ongoing
Distribution: Worldwide distribution.
A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Canary Islands, China, Colombia, Costa Rica...
Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.
Class IIReported ongoing
Distribution: Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Argentina, Aruba, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Cyprus, C...
inability to reprogram one device
Class IIReported ongoing
Distribution: International distribution in the country of UK.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 45 records, including 43 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.