Class IIOngoingZ-2912-2026
MICROVENTION INC. recalls BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-…
Due to an increase rate of balloon pinhole defects.
MICROVENTION INC.CAAug 19, 2026
Catheter, Percutaneous recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 18 recalls
Class IOngoingZ-2377-2026
ARROW INTERNATIONAL, LLC recalls Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X…
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if ster…
ARROW INTERNATIONAL, L…NCJun 24, 2026
Class IOngoingZ-0188-2026
BALT USA, LLC recalls Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Cata…
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
BALT USA, LLCCANov 5, 2025
Class IOngoingZ-2436-2025
Boston Scientific Corporation recalls WATCHMAN TruSteer Access System
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.…
Boston Scientific Corp…MNSep 10, 2025
Class IOngoingZ-2435-2025
Boston Scientific Corporation recalls WATCHMAN FXD Curve Access System Dbl
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.…
Boston Scientific Corp…MNSep 10, 2025
Class IOngoingZ-2434-2025
Boston Scientific Corporation recalls WATCHMAN FXD Curve Access System Sgl
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.…
Boston Scientific Corp…MNSep 10, 2025
Class IOngoingZ-2433-2025
Boston Scientific Corporation recalls WATCHMAN TruSeal Access System ANT
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.…
Boston Scientific Corp…MNSep 10, 2025
Class IOngoingZ-2432-2025
Boston Scientific Corporation recalls WATCHMAN TruSeal Access System DBL
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.…
Boston Scientific Corp…MNSep 10, 2025
Class IOngoingZ-2431-2025
Boston Scientific Corporation recalls WATCHMAN TruSeal Access System SGL
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.…
Boston Scientific Corp…MNSep 10, 2025
Class IOngoingZ-2430-2025
Boston Scientific Corporation recalls WATCHMAN FXD Curve Access Sys Dbl
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.…
Boston Scientific Corp…MNSep 10, 2025
Class IOngoingZ-2429-2025
Boston Scientific Corporation recalls WATCHMAN FXD Curve Access Sys Sgl
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.…
Boston Scientific Corp…MNSep 10, 2025
Class IOngoingZ-2428-2025
Boston Scientific Corporation recalls WATCHMAN TruSeal Access System ANT
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.…
Boston Scientific Corp…MNSep 10, 2025