Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-1582-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440

Product Classification:

Class II

Date Initiated: August 9, 2022

Date Posted: August 31, 2022

Recall Number: Z-1582-2022

Event ID: 90735

Reason for Recall:

The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

Status: Ongoing

Product Quantity: 184 devices (UPDATED)

Code Information:

UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025.

Distribution Pattern:

International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution.

Voluntary or Mandated:

Voluntary: Firm initiated