Z-0592-03

Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and...

Name: Z-0592-03 Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and...
Creator: Symbiosis Corp.
Published: 2002-11-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2002-11-19 / Terminated

FDA source

Symbiosis Corp. began a recall of Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therapeutic devices during Percutaneous... on 2002-11-19. The reason FDA records is "Product is mislabled as a ChoICE Floppy Guide Wire when it is actually a ChoICE ES(Extra Support) Guide Wire". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0592-03
Status: Terminated
Initiated: 2002-11-19
Posted: 2003-02-27
Terminated: 2008-04-15
Recalling firm: Boston Scientific Corporation
Product: Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therapeutic devices during Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures. The ChoICE guide wire contains a one-piece stainless steel core, which extends throughout the length of the wire and provides steerability and torqueability. The wire is tapered and formed at the distal tip. A radiopaque platinum spring coil surrounds the distal tip of the core wire. The ChoICE Guide Wire is a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. One side of the pouch is clear polyethylene/polyester laminate and the reverse side is Tyvek. The pouch assemblies are packaged in a five-pack product box. A flushing tool is included in the package to facilitate hydration of the coating with heparanized saline before use. 1, page 1, is a copy of the pouch label. Exhibit 1, page 2 is a copy of the five-pack product box label. Exhibit 2 is a copy of the Directions for Use.
Product code: DQX Wire, Guide, Catheter
Reason for recall: Product is mislabled as a ChoICE Floppy Guide Wire when it is actually a ChoICE ES(Extra Support) Guide Wire.
FDA root cause: Other
Action: Recall Letters issued 11/19/2002 via Federal Express to 7 hospital accounts. Consignees were requested to fill out a response form and return product to their Quincy, MA facility.
Quantity in commerce: 19/5-pack units
Distribution: Product was distributed to hospitals in FL, MI, GA, OR, ID AND CT. 05.
Product codes and lots: Individual pouch codes are coded catalog # 12132-01, batch 4785750 expiration date 2004-05 and the five pack outer boxes are coded: Catalog No. 12132-01, batch 4806821 expiration date 2004-5.

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)