Visions PV — Class II medical device recall Z-0727-2019
Terminated recall by Volcano Corporation, reported 2019-01-23. Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potentia
| Recall number | Z-0727-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2018-10-17 |
| Classified | 2019-01-11 |
| Reported by FDA | 2019-01-23 |
| Terminated | 2021-04-30 |
| Quantity | 1,240 units |
| Lot numbers | 0301418942, 0301418943, 0301420226, 0301420227, 0301424426, 0301424427, 0301425755, 0301425756, 0301425757, 0301425758, 0301430789, 0301430790, 0301430791, 0301430792, 0301431656, 0301431657, 0301431658, 0301438592, 0301438593, 0301440863, 0301441405, 0301441406, 0301442658, 0301446207, 0301450813, 0301450814, 0301453529, 0301453530, 0301453531, 0301457395, 0301457396, 0301457397, 0301457398, 0301462001, 0301462002, 0301462003, 0301465894, 0301465896, 0301465897, 0301469597 and 15 more |
| Model numbers | 81234/400-0200.272 |
Product
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.
Reason for recall
Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0727-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.