# FDA recall Z-0181-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2020-08-24.

## 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.

## Distribution

US Nationwide distribution including in the states of (1) MD (2) NY (3) MI (4) CT (5) SD (6) GA.

## Key facts

- **Recall number:** Z-0181-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-24
- **Report date:** 2020-10-28
- **Termination date:** 2024-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Quincy, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0181-2021

## Citation

> AI Analytics. FDA recall Z-0181-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0181-2021. Source: US FDA. Licensed CC0.

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