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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90252

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 13, 2022
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Volcano Corp

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

Z-1301-2022
Recall number
Z-1301-2022
Initiated
May 13, 2022
Classification
Class III
Status
Ongoing
Recalling firm
Volcano Corp
Quantity
14.031 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

Code information

All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of NY, CA, AZ, LA, NV, AL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, VA, SD, TN, MA, DE, NE, MT, CT, WV, WA, IN, IA, HI, NH, WY, UT, ID, DC, RI, NM, ME, VT and the countries of ES, SE, FR, PR, IT, DE, CA, NZ, PL, BR, ZA, NL.

device · product 2 of 2

Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797

Z-1302-2022
Recall number
Z-1302-2022
Initiated
May 13, 2022
Classification
Class III
Status
Ongoing
Recalling firm
Volcano Corp
Quantity
7,520 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

Code information

All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 ,; UDI/DI: 00845225002596

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of NY, CA, AZ, LA, NV, AL, MI, WI, CO, TX, NJ, OR, FL, KS, IL, MD, PA, OH, NC, OK, MN, AK, GA, MO, SC, MS, KY, AR, VA, SD, TN, MA, DE, NE, MT, CT, WV, WA, IN, IA, HI, NH, WY, UT, ID, DC, RI, NM, ME, VT and the countries of ES, SE, FR, PR, IT, DE, CA, NZ, PL, BR, ZA, NL.