FDA Device recall Z-1844-2015
Volcano PV .035 Catheter: Part number: 88901
- FDA Device
- Class II
- terminated
- Published 2015-07-01
On 2015-07-01 the FDA classified a Class II recall of Volcano PV .035 Catheter: Part number: 88901 by Volcano, citing during a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1844-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-04 |
| Published | 2015-07-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Volcano |
| Distribution | US |
Product
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Reason
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
Identifiers
| code_info | Product number 88901; lot number 50002518 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Volcano
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
FDA Device · Class II · 2026-10-07 · Volcano - Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P
FDA Device · Class II · 2025-08-06 · Volcano - Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
FDA Device · Class III · 2022-07-06 · Volcano - Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
FDA Device · Class II · 2022-06-22 · Volcano
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1844-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.