Z-1097-03

Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 37915-4020

Name: Z-1097-03 Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 37915-4020
Creator: Boston Scientific Scimed
Published: 2003-07-01
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-07-01 / Terminated / root cause: packaging

FDA source

Boston Scientific Scimed began a recall of Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 37915-4020 on 2003-07-01. The reason FDA records is "Some of the product pouches have holes in the seals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1097-03
Status: Terminated
Initiated: 2003-07-01
Posted: 2003-08-12
Terminated: 2006-12-28
Recalling firm: Boston Scientific Corporation
Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 37915-4020
Product code: GBR
Reason for recall: Some of the product pouches have holes in the seals.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
Quantity in commerce: 85
Distribution: The recalled products were shipped to hospitals located nationwide in the United States.
Product codes and lots: Lot numbers 5462665, 5486700, 5509423, 5570097, 5580887, 5591636, and 5592100

Product code GBR

K021735Class IIBoston Scientific Ultra-Soft Sv Balloon Dilatation CatheterBoston Scientific Scimed, Inc. / cleared 2002-08-08

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)