FDAMarch 30, 2022device
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential that the proximal marker may separate from the imaging catheter
What to do
FDA enforcement status: Ongoing
Brands named
abbott vascularabbott
UPCs
05415067031129827412881471880541506703111281313638211511821151581849798185100821152081927918256954
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software2026-05-12
- FDAi-STAT G3+ cartridge; List Number: 03P78-26;2026-04-01
- FDAi-STAT EG7+ cartridge; List Number: 03P76-25;2026-04-01
- FDAi-STAT EG6+ cartridge; List Number: 03P77-25;2026-04-01
- FDAArtegraft Vascular Graft; REF#: AG740;2026-02-10
- FDAProduct Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable2026-02-09
- FDABroviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 600602025-12-12
- FDAFreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.2025-11-24
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