Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Reason: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determine...
Z-2535-2025September 17, 2025Maple Grove, MN
Medtronic Perfusion Systems
Class IOngoing
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Reason: The catheters may not retain their shape.
Z-2482-2025September 10, 2025Brooklyn Park, MN
Medtronic Perfusion Systems
Class IOngoing
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Reason: The catheters may not retain their shape.
Z-2481-2025September 10, 2025Brooklyn Park, MN
Merge Healthcare, Inc.
Class IIOngoing
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that m...
Reason: Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error mes...
Z-2518-2025September 10, 2025Hartland, WI
Medtronic Perfusion Systems
Class IOngoing
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Reason: The catheters may not retain their shape.
Z-2480-2025September 10, 2025Brooklyn Park, MN
C.R. Bard Inc
Class IIOngoing
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A31951...
Reason: Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfuncti...
Z-2462-2025September 3, 2025Covington, GA
MEDLINE INDUSTRIES, LP - Northfield
Class IOngoing
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH...
Reason: Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
Reason: Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not con...
Z-2298-2025August 20, 2025Clarksville, TN
Boston Scientific Corporation
Class IIOngoing
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Reason: The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Z-2278-2025August 20, 2025Saint Paul, MN
Volcano Corp
Class IIOngoing
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
Reason: Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require...
Z-2221-2025August 6, 2025San Diego, CA
Boston Scientific Corporation
Class IIOngoing
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardio...
Reason: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst ca...
Z-2106-2025July 16, 2025Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various...
Reason: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst ca...
Z-2105-2025July 16, 2025Saint Paul, MN
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
Reason: Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertio...
Z-2044-2025July 9, 2025Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3)...
Reason: Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertio...
Z-2043-2025July 9, 2025Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
Reason: Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertio...
Z-2045-2025July 9, 2025Northfield, IL
Becton Dickinson Infusion Therapy Systems, Inc.
Class IIOngoing
REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2000-2025July 2, 2025Sandy, UT
Becton Dickinson Infusion Therapy Systems, Inc.
Class IIOngoing
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2002-2025July 2, 2025Sandy, UT
Becton Dickinson Infusion Therapy Systems, Inc.
Class IIOngoing
REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2004-2025July 2, 2025Sandy, UT
Becton Dickinson Infusion Therapy Systems, Inc.
Class IIOngoing
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-1999-2025July 2, 2025Sandy, UT
Becton Dickinson Infusion Therapy Systems, Inc.
Class IIOngoing
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2001-2025July 2, 2025Sandy, UT
Becton Dickinson Infusion Therapy Systems, Inc.
Class IIOngoing
REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2006-2025July 2, 2025Sandy, UT
Becton Dickinson Infusion Therapy Systems, Inc.
Class IIOngoing
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2005-2025July 2, 2025Sandy, UT
Becton Dickinson Infusion Therapy Systems, Inc.
Class IIOngoing
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2003-2025July 2, 2025Sandy, UT
Becton Dickinson Infusion Therapy Systems, Inc.
Class IIOngoing
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Reason: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Z-2007-2025July 2, 2025Sandy, UT
Cook Incorporated
Class IOngoing
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft len...
Reason: Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.