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RecallWatchMedical Device Safety
Class IIOngoingZ-2912-2026

MICROVENTION INC. recalls BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-…

MICROVENTION INC.Aliso Viejo, CA, United StatesReported Aug 19, 2026 · 7 days ago
Legal News Analyst ·

Reason for recall

Due to an increase rate of balloon pinhole defects.

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

  • BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems
    UDI codesCatalog # Number
    166 affected lots
    0001218734000122284400012241370001226522000126437200012813080001283704BOB-895-EMEA
    +158 more000075659600007840410000823532000091266700007573840000799436000082825000009159550000758945000080218300008305290000919813000076527000008026190000836906000092293000007676600000809792000083778500009273450000772588000081281200008632560000930383000077488500008144980000866698000093745800007780890000816560000087413800009458550000779647000081887600008759760000976589000078124000008234040000906381BOB-895-EMEA-AL0000985070000103163300011012330001136555000099116800010534170001103095000114474500009928100001055173000110460200011464710000993790000105647000011086500001147975000099482900010604640001110938000115839900009955650001061678000111236600011718400000996450000106235400011134740001173474000101581700010683540001115761000117497600010160020001069356000111718500011765010001018992000107120700011189730001178541000102187800010728980001120771000119758200010231070001074123000112193400012027660001025449000108315600011230770001210548000102825500010858500001125524000102997400010936960001128348BOB-895-US00010798880001081226000114118600011731790001262241000143710100014386740001441913000144380200014460690001453708MV-BGA0109500010402270001107168000129269900013840370001042037000114118200012940200001447547000104493700011522310001313654000145676000010469840001154356000132485500014580080001047845000118505600013277050001461756000104968000012251260001338930000146457900010517710001246712000134037400014669460001065613000125274100013544790001467787000107600100012666510001355468000146778900010787980001269171000135865300014703370001097321000128719000013681840001485515000110593900012895380001372365

What the firm is doing

On 04/30/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was mailed to customers informing them that due to an increased rate of balloon pinhole defects (inflation-related issues). Customers are instructed to: 1. Immediately stop using and quarantine the affected BOBBY Balloon Guide Catheters 2. Reconcile, complete and return the "CUSTOMER ACKNOWLEDGEMENT FORM" via email to Terumo4118@sedgwick.com or FAX +1 877-650-7688 and return affected products. 3. Provide Recall Letter to any/all medical facilities to your organization has distributed recalled products to. 4. Return Product -Return product through provided Ground Return Service or Return Service Label receipt provided in this recall notification and ship the products to Processing Center through the below contact. Ship to Address 2670 Executive Drive Suite A Indianapolis, IN 46241 USA -Credit will be issued for customer purchased products upon return and verification of recall unit(s). For Questions or further assistance - contact Sedgwick at +1 877-650-7686 or direct any questions to Terumo Neuro Sr. Director of Post Market Surveillance at +1 949-899-7194 Monday -Friday 8:00 a.m. to 5:00 p.m. (PST) or email recalls@microvention.com

DistributionShow details

Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Ukraine, and United Kingdom. Asia - China, Japan, Jordan, New Zealand, South Korea, and United Arab Emirates.

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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