Z-1541-06

Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack...

Name: Z-1541-06 Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack...
Creator: Boston Scientific
Published: 2006-08-31
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-08-31 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific began a recall of Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic... on 2006-08-31. The reason FDA records is "The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip". 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-1541-06
Status: Terminated
Initiated: 2006-08-31
Posted: 2006-09-29
Terminated: 2007-06-26
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip. Made in USA.
Product code: DQX Wire, Guide, Catheter
Reason for recall: The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: An Urgent Medical Device Recall letter, dated 08/31/06, was sent to affected customers. The letter describes the issue,states that distribution or use of affected product should cease immediately and replacement product will be issued for all returned devices. A Reply Verification Tracking Form is asked to be completed and returned to Boston Scientific.
Quantity in commerce: 343 Total. 329-US, 14-Foreign
Distribution: Worldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countries of Austria, Belgium, Bulgaria, Chile, Columbia, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Mexico, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela.
Product codes and lots: Single Pack - Outer Box UPN H7493893104J0, Inner Pouch UPN H7493893104J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8578445/8498450; 8615997/8579187; 8616986/8428651; 8625889/8542669; 8634387/8592510; 8661236/8615192; 8676306/8623927; 8679477/8614968; 8684638/8614969; 8691987/8614967; 8711404/8615194; 8711707/8640992; 8716167/8615190; 8775301/8721349. 5-Pack - Outer Box UPN H7493893104J2, Inner Pouch UPN H7493893104J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8578446/8498450; 8615998/8579187; 8616987/8428651; 8625890/8542669; 8634388/8592510; 8661241/8615192; 8676307/8623927; 8679478/8614968; 8684639/8614969; 8691990/8614967; 8711405/8615194; 8711708/8640992; 8716168/8615190; 8775302/8721349.

Product code DQX

K030617Class IIPt2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc. / cleared 2003-05-21

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)