FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA. Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9. Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8. Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6. The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.
- Recall number
- Z-0264-2012
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA. Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9. Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8. Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6. The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.
- Status
- Terminated
- Initiated
- 2011-11-03
- Posted
- 2011-11-21
- Terminated
- 2013-01-15
- Reason
- Boston Scientific is initiating a medical device recall removal regarding nine lots/batches of Super Sheath and Super Sheath R/O Introducer Sheaths. Boston Scientific was informed through product complaints that the 0.035" ID dilator may be labeled incorrectly as a 0.038" ID dilator.
- Root cause
- Packaging process control
- Action
- Boston Scientific sent an URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED letter dated November 21, 2011. The letter described the product and the problem. Customers were instructed to segregate the affected product immediately and return it to Boston Scientific. Distributors were advised that the recall removal depth is to the hospital level and the recall removal notification should be forwarded to their customers. For questions regarding this recall call 763-494-1133.
- Quantity
- 2660
- Distribution
- Worldwide Distribution - USA including AZ, AR, CA, CO, FL, GA, IL, KY, LA, MD, MA, MN, MO, NE, NJ, NM, NY, OH, OK PA, RI, TN, TX, UT, VA, WY, WI, and WV and the countries of BELGIUM, BRAZIL, CZECH REPUBLIC, FRANCE, GERMANY, GREAT BRITAIN, IRAQ, ITALY, NETHERLANDS, RUSSIAN FEDERATION, SOUTH KOREA, SPAIN, SWEDEN, and UKRAINE.
- Lot, serial or model codes
- 11B15B6 11B23B7 11B28B9 11C09BA 11C16B9 11C30B9 11C07B8 11B01B4 11B25B6
- 510(k) numbers
- ["K052557"]
- PMA numbers
- not on file
- Product code
- DRE
- 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