FDA recall Z-2674-2017

Product

Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340

Reason for recall

Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon

Distribution

MI, MO Foreign: Austria France Great Britain Italy Spain Sweden

Key facts

Status

Terminated

Initiation date

2017-06-01

Report date

2017-07-12

Termination date

2018-06-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2674-2017