Z-0591-03

Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm length

Name: Z-0591-03 Scimed PT Graphix Intermediate PCTA 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 PT Graphix Intermediate PCTA 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-0591-03
Status: Terminated
Initiated: 2002-08-22
Posted: 2003-02-27
Terminated: 2012-07-13
Recalling firm: Boston Scientific Corporation
Product: Scimed PT Graphix Intermediate PCTA 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: 228/5 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 as follows: Catalog No. 14914-01 UPN H74914914011 Lot Number Expiration Date 4772607 2004-0 4772610 '' 4762379 '' 4762384 '' 4772618 '' 4766619 '' 4758393 '' 4758432 '' 4753775 '' 4758389 '' 4758427 '' 4756521 '' 4762390 '' 4756485 '' 4753781 '' 4758397 '' 4758423 '' 4753783 '' 4753785 '' 4740328 2004-4 4753779 2004-5 4753759 '' 4753769 '' 4756534 '' 4756536 '' 4756531 '' 4724690 2004-4 4740329 '' 4736552 '' The above PT Graphix¿ guide wire pouch lots were packaged in 18 lots of five-pack boxes with the following codes: Catalog No. 1215T UPN H74914914012 Lot Number Expiration Date 4789558 2004-05 4791600 '' 4789558 '' 4791126 '' 4785009 '' 4787988 '' 4786427 '' 4783177 '' 4780051 '' 4780186 '' 4783316 '' 4780190 '' 4782079 '' 4780939 '' 4771889 '' 4777410 '' 4775761 '' 4776272 '' 4766792 ''

Product code DQX

K962572Class IIScimed Choice Pt Vision Ptca Guide WireScimed Life Systems, Inc. / cleared 1996-12-17

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)