Microvention BOBBY Balloon Guide Catheter Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Microvention Inc. is recalling 5,500 BOBBY Balloon Guide Catheters worldwide due to an increased rate of balloon pinhole defects.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 25, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
Microvention Inc. initiated a voluntary recall of BOBBY Balloon Guide Catheters due to an increased rate of balloon pinhole defects. The recall is classified as Class II by the FDA and remains ongoing.
Which Products Are Affected
The affected products are BOBBY Balloon Guide Catheter with catalog numbers BOB-895-CN, BOB-895-EMEA, BOB-895-EMEA-AL, BOB-895-US, and MV-BGA01095. A total of 5,500 devices are involved. Distribution includes the United States (states: 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, WI) and countries in Europe, Asia, South Africa, and New Zealand. Specific lot numbers and UDI codes are listed in the FDA recall notice Z-2912-2026.
What You Should Do
The recall was initiated via letter. Consumers and healthcare providers should refer to the recalling firm for further guidance on affected units.
Why This Matters
The devices are used to facilitate insertion and guidance of intravascular catheters in peripheral and neurovascular systems, and the defect may impact product performance.
Source
FDA recall number Z-2912-2026; Microvention Inc., Aliso Viejo, CA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,178 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 25, 2026.
Frequently Asked Questions
Common questions about this FDA recall.