CLASS III ONGOING Device recall · Reported 6 Jul 2022 · FDA Enforcement Report
Visions PV. 035 Digital IVUS Catheter recalled by Volcano
Volcano is recalling Visions PV. 035 Digital IVUS Catheter, distributed nationwide in the US. The recall was initiated on 13 May 2022 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1302-2022
- FDA event ID
- 90252
- Recalling firm
- Volcano, San Diego, CA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 13 May 2022
- FDA classified
- 29 Jun 2022
- Reported
- 6 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 13 May 2022 | Recall initiated by company | |
| 29 Jun 2022 | Classified by FDA | +47 days |
| 6 Jul 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Product as listed by the FDA
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Which lots are affected?
All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 ,; UDI/DI: 00845225002596
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 90252This product is part of a recall event; the main page for the event is Visions PV. 035 Digital IVUS Catheter recalled by Volcano.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Visions PV. 035 Digital IVUS Catheter recalled by Volcano | Volcano | Other | Nationwide |
More recalls from Volcano
All 32| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips IntraSight Plus recalled by Volcano | Volcano | Device Malfunction | Nationwide |
| Device | CLASS II | Visions Digital IVUS Catheter: PV.014P (Platinum) recalled by Volcano | Volcano | Other | Nationwide |
| Device | CLASS III | Visions PV. 035 Digital IVUS Catheter recalled by Volcano | Volcano | Other | Nationwide |
| Device | CLASS II | Philips OmniWire Pressure guide wire recalled by Volcano | Volcano | Sterility | WA, WI |
| Device | CLASS III | Mm-tsm (Touch Screen Module/Secondary Controller/Bedside recalled | Volcano | Foreign Material | 50 states |
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|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |