FDA Medical Device Recalls (openFDA)
Boston Scientific: Boston Scientific IQ Guide Wire. Catalog No. 38950-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38950-012, 185 cm, Straight Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. 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.
- Recall number
- Z-1213-06
- Recalling firm
- Boston Scientific
- Product
- Boston Scientific IQ Guide Wire. Catalog No. 38950-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38950-012, 185 cm, Straight Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. 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.
- Status
- Terminated
- Initiated
- 2006-05-30
- Posted
- 2006-07-12
- Terminated
- 2007-06-28
- Reason
- Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off.
- Root cause
- Other
- Action
- On May 30, 2006, Boston Scientific notified customers of the IQ Guide Wire manufactured from February 3, 2006, through March 15, 2006. BSC requested a reply whether or not they still have product in their institution. Replacements will be issued for returned product. UPDATE: A second recall notification was sent to affected customers 07/07/06. This second notification included Inner Pouch Number (UPN) and Inner Pouch Lot/Batch #.
- Quantity
- 1455 units total
- Distribution
- Nationwide (AR, AZ, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, NC, NH, NJ, NM, NV, OH, OK, PA, TN, TX, UT, VA, WI, WV) and Puerto Rico. Chile, Germany, Taiwan.
- Lot, serial or model codes
- Catalog No. 38950-010 with Box Lot/Batch No. AND Inner-Pouch Lot/Batch No.: 8396722/8374308, 8397332/8374309, 8411208/8387184, 8414011/8398030, 8414321/8391628, 8414625/8394866, 8414627/8395261, 8414958/8391724, 8423202/8404318, 8423636/8398031, 8428184/8408727, 8430959/8404322, 8433309/8408726, 8433399/8403092, 8435627/8415782, 8437126/8415778, 8438614/8413997, 8439171/8419527, 8439179/8419528, 8440181/8419529. Catalog No. 38950-012 with Box Lot No. AND Inner-Pouch Lot/Batch No.: 8396863/8374308, 8397333/8374309, 8411209/8387184, 8414012/8398030, 8414319/8391628, 8414626/8394866, 8414628/8395261, 8414957/8391724, 8423343/8404318, 8423638/8398031, 8428185/8408727, 8430961/8404322, 8433308/8408726, 84333938403093, 8433400/4803092, 8435628/8415782, 8437125/8415778, 8438615/8413997, 8439172/8419527, 8439180/8419528, 8440182/8419529.
- 510(k) numbers
- ["K040140"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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