CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-50...
Reason: Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.
Z-1307-2025March 19, 2025Marlborough, MA
Cordis US Corp
Class IIOngoing
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary o...
Reason: Catheter manufactured at the incorrect length.
Z-1330-2025March 19, 2025Miami Lakes, FL
Bard Peripheral Vascular Inc
Class IOngoing
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Reason: Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected ...
Z-1244-2025March 12, 2025Tempe, AZ
Biosense Webster, Inc.
Class IOngoing
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used ...
Reason: Due to an observed trend of neurovascular events
Z-1205-2025March 12, 2025Irvine, CA
Scientia Vascular, Inc.
Class IIOngoing
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during inte...
Reason: Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Z-1235-2025March 5, 2025West Valley City, UT
Scientia Vascular, Inc.
Class IIOngoing
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute is...
Reason: Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Z-1234-2025March 5, 2025West Valley City, UT
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Reason: Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potenti...
Z-1173-2025February 26, 2025Northfield, IL
B. Braun Medical, Inc.
Class IIOngoing
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
Reason: Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the re...
Reason: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Z-1048-2025February 5, 2025Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IOngoing
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
Reason: The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Z-0992-2025February 5, 2025Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IOngoing
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE...
Reason: The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Z-0991-2025February 5, 2025Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Reason: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Reason: A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Z-0845-2025January 22, 2025Minneapolis, MN
ev3 Inc
Class IIOngoing
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40...
Reason: There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Z-0904-2025January 22, 2025Plymouth, MN
Beckman Coulter, Inc.
Class IIOngoing
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
Reason: Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an ...
Z-0727-2025January 1, 2025Chaska, MN
Abbott Vascular Inc
Class IIOngoing
20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
Reason: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Z-0730-2025January 1, 2025Temecula, CA
Abbott Vascular Inc
Class IIOngoing
20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherect...
Reason: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
Z-0731-2025January 1, 2025Temecula, CA
Spectranetics Corporation
Class IIOngoing
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW ...
Reason: Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.