Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term dura...
Z-0491-2025November 27, 2024Saint Paul, MN
Abbott Medical
Class IIOngoing
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term dura...
Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term dura...
Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term dura...
Z-0494-2025November 27, 2024Saint Paul, MN
Abbott Medical
Class IIOngoing
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Reason: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term dura...
Z-0492-2025November 27, 2024Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Z-0300-2025November 20, 2024Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Z-0297-2025November 20, 2024Saint Paul, MN
Bard Peripheral Vascular Inc
Class IIOngoing
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the...
Reason: The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. Thi...
Z-0371-2025November 20, 2024Tempe, AZ
Boston Scientific Corporation
Class IOngoing
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Ma...
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Z-0303-2025November 20, 2024Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Z-0301-2025November 20, 2024Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Z-0299-2025November 20, 2024Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Z-0302-2025November 20, 2024Saint Paul, MN
Boston Scientific Corporation
Class IOngoing
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Z-0298-2025November 20, 2024Saint Paul, MN
Covidien LP
Class IIOngoing
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US...
Reason: Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Z-0257-2025November 6, 2024Mansfield, MA
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ...
Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal ...
Z-0155-2025October 30, 2024Northfield, IL
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Class IIOngoing
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray...
Reason: If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then dire...
Z-0139-2025October 30, 2024Kyoto, N/A
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal ...
Z-0162-2025October 30, 2024Northfield, IL
Merit Medical Systems, Inc.
Class IIOngoing
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty cathete...
Reason: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Z-0057-2025October 23, 2024South Jordan, UT
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracar...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0104-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardia...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0099-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or int...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0106-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac a...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...