Class 2 Device Recall OptiCross 35 15 MHzPeripheral Imaging Catheter

• Date Initiated by Firm: August 24, 2020
• Create Date: October 22, 2020
• Recall Status: Terminated on April 05, 2024
• Recall Number: Z-0181-2021
• Recall Event ID: 86466
• 510(K)Number: K200733
• Product Classification: Catheter, ultrasound, intravascular - Product Code OBJ
• Product: Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
• Code Information: Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700
• FEI Number: 3001451463
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 500 Commander Shea Blvd; Quincy MA 02171-1518
• For Additional Information Contact: Nicole Pshon; 763-494-1133
• Manufacturer Reason for Recall: Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter. All recalled devices should be returned to Boston Scientific.
• FDA Determined Cause: Process control
• Action: All affected customers were sent a letter on 08/24/2020 stating the following: Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter. All recalled devices should be returned to Boston Scientific.
• Quantity in Commerce: 41 devices
• Distribution: US Nationwide distribution including in the states of (1) MD (2) NY (3) MI (4) CT (5) SD (6) GA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = OBJ