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iSLEEVE Introducer Set (Boston Scientific) – Hemostasis Concern (2024)

Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.

High

FDAFeb 20, 2024Nationwide• Boston Scientific Corporation

EsteemBody Soft Convex Pouch (ConvaTec) – Inconsistency Risk (2024)

Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.

Moderate

FDAFeb 19, 2024Nationwide• ConvaTec, Inc

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iSLEEVE Introducer Set (Boston Scientific) – Hemostasis Concern (2024)

EsteemBody Soft Convex Pouch (ConvaTec) – Inconsistency Risk (2024)

HeartMate 3 LVAS (Thoratec) – Outflow Graft Obstruction (2024)

HeartMate II LVAS (Thoratec) – Outflow Graft Obstruction (2024)

Neonatal ArcticGel Pads (Medivance) – Water Flow Issue (2024)

Abre Venous Stent System (Medtronic) – Package Breach (2024)

Origio Sperm Wash Medium (CooperSurgical) – Sodium Pyruvate Risk (2024)

CARTO VIZIGO Sheath (Biosense Webster) – Manufacturing Mix-Up (2024)

Rad-G Pulse Oximeter (Masimo) – Power Monitoring Risk (2024)

Mariner RDX Head (SeaSpine) – Screw Threading Risk (2024)

HotDog Return Electrode (Augustine) – Electrode Contact Issue (2024)

QXDx BCR-ABL Kit (Bio-Rad) – Calibration Inaccuracy (2024)

DIVA LCD Display (Philips) – Touch Input Malfunction (2024)

Rad-G Pulse Oximeter (Masimo) – Power Monitoring Risk (2024)

Covidien Signia Reload (Unknown) – Staple Line Disruption (2024)

Signia Curved Tip Reload (Unknown) – Staple Line Disruption (2024)

Cystatin C Calibrator (Randox) – Bias Concern (2024)

STERIS Traction Boot (Baxter) – Locking Pin Defect (2024)

GeoMed Tracecarts (DeRoyal) – Component Recall Risk (2024)

TMini Knee Instrument (Think Surgical) – Array Guide Issue (2024)