Home › Device types › LIT
Catheter, Angioplasty, Peripheral, Transluminal
FDA product code LIT · Class 2 · Cardiovascular
18,318
Registered devices
35,722
Adverse events
32
Recalls
403
510(k) clearances
Devices with this code
Polux PTA Balloon Dilatation Catheter — BrosMed Medical Co.,Ltd.Hermes NC PTA Balloon Dilatation Catheter — BrosMed Medical Co.,Ltd.Pacific™ Plus — MEDTRONIC, INC.Advance Serenity™ 18 — CREAGH MEDICAL LIMITEDSaberX Radianz — CORDIS CORPORATIONUltraverse® 035 PTA Dilatation Catheter — Bard Peripheral Vascular, Inc.EverCross™ — EV3, INCChocolate® — MEDTRONIC, INC.JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 14 OTW — OrbusNeich Medical (ShenZhen) Co., Ltd.JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 35 OTW — OrbusNeich Medical (ShenZhen) Co., Ltd.Victory 0.018" PTA OTW Catheter — NATEC MEDICAL LTDARROW — TELEFLEX INCORPORATEDPROTEUS — ANGIOSLIDE LTDPacific™ Plus — MEDTRONIC, INC.MUSTANG™ — BOSTON SCIENTIFIC CORPORATIONUltraverse® RX — Bard Peripheral Vascular, Inc.Armada — ABBOTT VASCULAR INC.PROTEUS — ANGIOSLIDE LTDZ-MED™ — B BRAUN INTERVENTIONAL SYSTEMS, INCEverCross™ — MEDTRONIC, INC.Atlas® Gold — Bard Peripheral Vascular, Inc.Atlas® — Bard Peripheral Vascular, Inc.Ultraverse® 014 — Bard Peripheral Vascular, Inc.Advocate — ARRAVASC LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-03 | Boston Scientific Corporation | Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Cat |
| 2025-07-21 | SUMMA THERAPEUTICS, LLC | Potential for the balloon in the device to not meet burst specifications. |
| 2024-12-10 | ev3 Inc | There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots. |
| 2024-09-19 | Covidien LP | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. |
| 2021-12-17 | Covidien Llc | The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive fo |
| 2021-07-19 | Cordis Corporation | The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer ove |
| 2021-07-14 | Ostial Corporation | Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of a |
| 2020-08-26 | ev3 Inc. | Labeling discrepancy for the Rated Burst Pressure (RBP) value. |
| 2020-01-08 | Cordis Corporation | Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area. |
| 2019-10-11 | Nucryo Vascular Inc. | Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.