Z-2674-2017Class II

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

Name: Z-2674-2017 Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Creator: Boston Scientific Corporation
Published: 2017-06-01
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-06-01 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340 on 2017-06-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2674-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-01
Posted: 2019-07-09
Terminated: 2018-06-26
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Boston Scientific Notifications to US consignees sent via Federal Express Priority mail on June 1, 2017. The notification instructs the account to check inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact: Brendan Smith, Boston Scientific Quality Systems, 763-494-1133 [email protected].
Quantity in commerce: 32 units
Distribution: MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
Product codes and lots: Lot Number: 19343209 Exp: 6/3 0/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2674-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2673-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03
Z-2674-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03

Product code FGE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)