Opticross 35 15 MHz Peripheral Imaging Catheter 8F — Class II medical device recall Z-0181-2021
Terminated recall by Boston Scientific Corporation, reported 2020-10-28, distributed nationwide. Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings
| Recall number | Z-0181-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Quincy, MA, United States |
| Recall initiated | 2020-08-24 |
| Classified | 2020-10-22 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2024-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 41 devices |
| UPC / GTIN / UDI-DI | 08714729984542 |
| Lot numbers | 25754545, 2582106, 25852104, 25856700 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0181-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.