Z-0590-03

Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length

Name: Z-0590-03 Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length
Creator: Symbiosis Corp.
Published: 2002-08-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2002-08-22 / Terminated / root cause: labeling and UDI

FDA source

Symbiosis Corp. began a recall of Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length on 2002-08-22. The reason FDA records is "Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0590-03
Status: Terminated
Initiated: 2002-08-22
Posted: 2003-02-27
Terminated: 2012-07-13
Recalling firm: Boston Scientific Corporation
Product: Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length
Product code: DQX Wire, Guide, Catheter
Reason for recall: Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Recall letters with response forms were sent to hosptials via FED EX on 8/22/02. Product was to be returned to Boston Scientific in Quincy, MA.
Quantity in commerce: 27/5 pack boxes
Distribution: Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts.
Product codes and lots: Individual Devices in Pouches with Catalog No. 12155-01, UPN H74912155011, Lot Number 4773987, exp. date 2004-5. These pouches were packaged in two lots of five-pack boxes with the following codes: Catalog 12155-01, lot 4791304 Catalog 12155-01, lot 4798294

Product code DQX

K960657Class IIScimed Choice Pt Exchange Extra Support Ptca and Long Taper Ptca Guide WireScimed Life Systems, Inc. / cleared 1996-04-29

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)