Recall Z-0181-2021 ยท OBJ Catheter, Ultrasound, Intravascular
Boston Scientific Corporation
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 translum
| Date | Aug 24, 2020 |
| Status | Terminated |
| Reason | 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 r |
| Root 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 occu |
| Quantity | 41 devices |
| Distribution | US Nationwide distribution including in the states of (1) MD (2) NY (3) MI (4) CT (5) SD (6) GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200733 | Opticross 35 15 MHz Peripheral Imaging Catheter Boston Scientific Corporation, Apr 17, 2020 |