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RecallWatchMedical Device Safety
Class IIOngoingZ-1704-2025

Medtronic Neuromodulation recalls Enhanced Verify Evaluation Handset (CFN HH90130FA)

Medtronic NeuromodulationMinneapolis, MN, United StatesReported May 7, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Enhanced Verify Evaluation Handset (CFN HH90130FA)UDI
    UDI-DI 00763000930042
    400 affected lots
    NPN0076461NPN0076462NPN0076465NPN0076466NPN0076467NPN0076468NPN0076469NPN0076470
    +392 moreNPN0076471NPN0076472NPN0076473NPN0076474NPN0076475NPN0076476NPN0076477NPN0076479NPN0076480NPN0076482NPN0076483NPN0076485NPN0076486NPN0076487NPN0076488NPN0076489NPN0076490NPN0076491NPN0076492NPN0076493NPN0076494NPN0076495NPN0076496NPN0076497NPN0076498NPN0076499NPN0076500NPN0076501NPN0076502NPN0076504NPN0076505NPN0076506NPN0076507NPN0076508NPN0076509NPN0076510NPN0076511NPN0076512NPN0076513NPN0076514NPN0076515NPN0076516NPN0076517NPN0076518NPN0076520NPN0076522NPN0076523NPN0076524NPN0076525NPN0076526NPN0076527NPN0076528NPN0076529NPN0076530NPN0076531NPN0076532NPN0076533NPN0076534NPN0076535NPN0076536NPN0076537NPN0076538NPN0076539NPN0076540NPN0076541NPN0076542NPN0076543NPN0076545NPN0076546NPN0076548NPN0076550NPN0076551NPN0076552NPN0076553NPN0076554NPN0076555NPN0076556NPN0076557NPN0076558NPN0076559NPN0076560NPN0076561NPN0076562NPN0076563NPN0076564NPN0076565NPN0076566NPN0076567NPN0076568NPN0076569NPN0076570NPN0076571NPN0076572NPN0076573NPN0076575NPN0076577NPN0076578NPN0076579NPN0076580NPN0076581NPN0076582NPN0076583NPN0076584NPN0076585NPN0076586NPN0076587NPN0076588NPN0076589NPN0076590NPN0076591NPN0076593NPN0076594NPN0076596NPN0076598NPN0076599NPN0076602NPN0076603NPN0076605NPN0076607NPN0076608NPN0076609NPN0076610NPN0076611NPN0076612NPN0076613NPN0076614NPN0076616NPN0076617NPN0076618NPN0076619NPN0076620NPN0076621NPN0076622NPN0076623NPN0076624NPN0076625NPN0076626NPN0076627NPN0076628NPN0076629NPN0076630NPN0076631NPN0076632NPN0076633NPN0076634NPN0076635NPN0076636NPN0076637NPN0076638NPN0076639NPN0076640NPN0076641NPN0076642NPN0076643NPN0076644NPN0076645NPN0076646NPN0076647NPN0076649NPN0076650NPN0076651NPN0076655NPN0076656NPN0076657NPN0076658NPN0076659NPN0076661NPN0076662NPN0076663NPN0076664NPN0076666NPN0076668NPN0076669NPN0076672NPN0076673NPN0076674NPN0076675NPN0076676NPN0076677NPN0076678NPN0076679NPN0076680NPN0076681NPN0076682NPN0076683NPN0076685NPN0076686NPN0076687NPN0076688NPN0076689NPN0076690NPN0076691NPN0076693NPN0076694NPN0076695NPN0076696NPN0076697NPN0076698NPN0076699NPN0076700NPN0076701NPN0076702NPN0076703NPN0076704NPN0076705NPN0076706NPN0076707NPN0076708NPN0076709NPN0076710NPN0076711NPN0076712NPN0076713NPN0076714NPN0076715NPN0076716NPN0076717NPN0076718NPN0076720NPN0076721NPN0076722NPN0076723NPN0076724NPN0076725NPN0076726NPN0076727NPN0076728NPN0076729NPN0076730NPN0076731NPN0076732NPN0076733NPN0076734NPN0076735NPN0076748NPN0076749NPN0076758NPN0077011NPN0077012NPN0077013NPN0077016NPN0077027NPN0077029NPN0077030NPN0077033NPN0077034NPN0077036NPN0077040NPN0077059NPN0077065NPN0077072NPN0077076NPN0077079NPN0077084NPN0077090NPN0077091NPN0077093NPN0077094NPN0077095NPN0077099NPN0077100NPN0077102NPN0077109NPN0077116NPN0077119NPN0077122NPN0077125NPN0077126NPN0077130NPN0077132NPN0077133NPN0077134NPN0077143NPN0077148NPN0077158NPN0077159NPN0077161NPN0077162NPN0077164NPN0077165NPN0077167NPN0077168NPN0077169NPN0077170NPN0077171NPN0077172NPN0077173NPN0077174NPN0077175NPN0077176NPN0077177NPN0077178NPN0077179NPN0077180NPN0077181NPN0077184NPN0077186NPN0077189NPN0077190NPN0077192NPN0077193NPN0077194NPN0077195NPN0077196NPN0077197NPN0077198NPN0077199NPN0077200NPN0077201NPN0077202NPN0077203NPN0077204NPN0077205NPN0077206NPN0077207NPN0077208NPN0077209NPN0077210NPN0077211NPN0077212NPN0077213NPN0077214NPN0077215NPN0077216NPN0077218NPN0077219NPN0077220NPN0077221NPN0077222NPN0077225NPN0077226NPN0077227NPN0077228NPN0077229NPN0077230NPN0077231NPN0077232NPN0077233NPN0077234NPN0077235NPN0077236NPN0077237NPN0077238NPN0077239NPN0077240NPN0077241NPN0077242NPN0077243NPN0077244NPN0077245NPN0077246NPN0077247NPN0077248NPN0077249NPN0077250NPN0077251NPN0077252NPN0077253NPN0077256NPN0077257NPN0077258NPN0077259NPN0077260NPN0077261NPN0077262NPN0077263NPN0077264NPN0077265NPN0077266NPN0077267NPN0077268NPN0077269NPN0077270NPN0077271NPN0077272NPN0077273NPN0077274NPN0077275NPN0077276NPN0077277NPN0077278NPN0077279NPN0077280NPN0077281NPN0077282NPN0077283NPN0077284NPN0077285NPN0077286NPN0077287NPN0077289NPN0077290

What the firm is doing

Firm began notifying Medtronic representatives on April 3, 2025. If impacted devices were found to be with a consignee, the representative will connect with the consignee to provide a copy of the Customer Letter, obtain a signed copy of the Customer Confirmation Form, and retrieve the impacted device. Customers were informed that their Medtronic representative will collect the affected devices and arrange for replacement devices.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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