Boston Scientific: Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. 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.

Recall number

Z-1538-06

Recalling firm

Boston Scientific

Product

Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. 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.

Status

Terminated

Initiated

2006-08-31

Posted

2006-09-29

Terminated

2007-06-26

Reason

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

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

1,423 total. 168-US, 1,255-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.

Lot, serial or model codes

Single Pack - Outer Box UPN H7493893101J0, Inner Pouch UPN H7493893101J0 with the following Outer Box Batch number / Inner Pouch Batch number: 854993/8506164; 8553464/8506163; 8558452/8506162; 8580516/8418120; 8581252/8414121; 8601289/8567104; 8601977/7567103; 8611497/8390776; 8618382/8414119; 8625209/8525244; 8630091/8602645; 8630092/8599793; 8637044/8599796; 8639684/8602647; 8642791/8599795; 8643583/8616749; 8645466/8616759; 8646331/8616971; 8650221/8599794; 8656280/8616970; 8656289/8612088; 8662274/8599797; 8662896/8616760; 8666532/8632041; 8668106/8602646; 8669915/8642147; 8681003/8641004; 8684067/89641006; 8694117/8642148; 8697663/8525245; 8699505/8642146; 8709594/8519073; 8749798/8713578; 8752423/8695650; 8761674/8721471; 8762199/8721350; 8774436/8742235; 8782981/8755555; 8783262/8742236; 8784950/8739386; 8795581/8755557; 8797321/8757433.   5-pack - Outer Box UPN H7493893101J2, Inner Pouch UPN H7493893101J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8553465/8506163; 8558453/8506162; 8642073/8607723; 8642792/8599795; 8643584/8616749; 8645467/8616759; 8646332/8616971; 8646667/8607724; 8650220/8599794; 8654220/8612089; 8656281/8616970; 8656290/8612088; 8662275/8599797; 8667578/8641003; 8668107/8602646; 8669916/8642147; 8677642/8519074; 8681004/8641004; 8683824/8530667; 8696525/8642150; 8697664/8525245; 8699506/8642146; 8776585/8739387.

510(k) numbers

["K030617"]

PMA numbers

not on file

Product code

DQX

Firm FEI

3002095335

Firm city

Maple Grove

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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