FDA Device recall Z-1555-2020

Imager II 5F Angiographic Catheters, 5 units per package

FDA Device
Class I
ongoing
Published 2020-04-01

On 2020-04-01 the FDA classified a Class I recall of Imager II 5F Angiographic Catheters, 5 units per package by Boston Scientific, citing potential for tip detachment of Imager II 5F Angiographic Catheters.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1555-2020
Classification	Class I
Status	ongoing
Initiated	2020-02-11
Published	2020-04-01
Last updated	2026-09-13 11:55 UTC
Company	Boston Scientific
Distribution	US

Product

Imager II 5F Angiographic Catheters, 5 units per package.

Reason

Potential for tip detachment of Imager II 5F Angiographic Catheters

Identifiers

code_info	All lots of the following: 1 Material Number (UPN) Outer Package M001314041, Material Number (UPN) Inner Package M0013… All lots of the following: 1 Material Number (UPN) Outer Package M001314041, Material Number (UPN) Inner Package M001314040 2 Material Number (UPN) Outer Package M001314051, Material Number (UPN) Inner Package M001314050 3 Material Number (UPN) Outer Package M001314061, Material Number (UPN) Inner Package M001314060 4 Material Number (UPN) Outer Package M001314071, Material Number (UPN) Inner Package M001314070 5 Material Number (UPN) Outer Package M001314081, Material Number (UPN) Inner Package M001314080 6 Material Number (UPN) Outer Package M001314091, Material Number (UPN) Inner Package M001314090 7 Material Number (UPN) Outer Package M001314101, Material Number (UPN) Inner Package M001314100 8 Material Number (UPN) Outer Package M001314111, Material Number (UPN) Inner Package M001314110 9 Material Number (UPN) Outer Package M001314121, Material Number (UPN) Inner Package M001314120 10 Material Number (UPN) Outer Package M001314131, Material Number (UPN) Inner Package M00

code_info

All lots of the following: 1 Material Number (UPN) Outer Package M001314041, Material Number (UPN) Inner Package M0013…

All lots of the following: 1 Material Number (UPN) Outer Package M001314041, Material Number (UPN) Inner Package M001314040 2 Material Number (UPN) Outer Package M001314051, Material Number (UPN) Inner Package M001314050 3 Material Number (UPN) Outer Package M001314061, Material Number (UPN) Inner Package M001314060 4 Material Number (UPN) Outer Package M001314071, Material Number (UPN) Inner Package M001314070 5 Material Number (UPN) Outer Package M001314081, Material Number (UPN) Inner Package M001314080 6 Material Number (UPN) Outer Package M001314091, Material Number (UPN) Inner Package M001314090 7 Material Number (UPN) Outer Package M001314101, Material Number (UPN) Inner Package M001314100 8 Material Number (UPN) Outer Package M001314111, Material Number (UPN) Inner Package M001314110 9 Material Number (UPN) Outer Package M001314121, Material Number (UPN) Inner Package M001314120 10 Material Number (UPN) Outer Package M001314131, Material Number (UPN) Inner Package M00

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1555-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.