Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported July 6, 2022
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Volcano Corp recalled Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Steril… - a low-severity action.
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Steril… was recalled by Volcano Corp in July 6, 2022. Reason: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications. Check the official notice for the remedy. Verify recall #Z-1301-2022 with the FDA Devices before acting.
The recall
Volcano Corp issued this low-severity FDA Devices recall-Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications.
- Low
- severity level
- 14 units
- affected scope
- Class III
- classification
- July 6, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1301-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1301-2022) was formally reported on July 6, 2022, with the manufacturer initiating the action on May 13, 2022. It is classified under Low severity (Class III), with a current status of Ongoing. Volcano Corp is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 14.031 units.
The documented reason for this recall is: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications Distribution data in the federal record shows the product reached: 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, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
14.031 units
Related Recalls
6
3 from same agency
Product description
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Reason for recall
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-1301-2022 |
| Date reported | July 6, 2022 |
| Date initiated | May 13, 2022 |
| Recalling firm | Volcano Corp |
| Firm location | San Diego, CA |
| Affected scope | 14.031 units |
| Distribution | 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, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1301-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797. Recalled by Volcano Corp. Units affected: 14.031 units.
Why was this product recalled? ▼
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2022. Severity: Low. Recall number: Z-1301-2022.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1301-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 6, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.